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- Acquired immune deficiency syndrome, acquired immunodeficiency syndrome, AIDS, antiretroviral, antiretroviral therapy, ART, AZT, CD4 T-cells, CD4+ T cells, CD8 T-cells, CD8+ T cells, consumer-controlled test kits, Durban Declaration, fusion inhibitor, HAART, highly active antiretroviral therapy, HIV-1, HIV-2, hivid, home testing kit, human immunodeficiency virus, IDU, immune, immune defense system, immune response, immunocompromised, immunodeficiency, injection drug use, Kaposi's sarcoma, lymphocytes, MAC infections, Mycobacterium avium complex infections, non-nucleoside reverse transcriptase inhibitor, nucleoside reverse transcriptase inhibitor, opportunistic infection, PCP, Pneumocystis carinii pneumonia, Pneumocystis jiroveci pneumonia, protease inhibitor, rapid test, retrovirus, sexually transmitted diseases, sexually transmitted infections, SIDA, STD, STI, viral infection, virus, weakened immune system, white blood cells.
- The human immunodeficiency virus (HIV) is the virus that potentially causes AIDS (acquired immune deficiency syndrome). HIV primarily attacks the immune defense system, making the patient extremely vulnerable to opportunistic infections, which are infections that occur in people who have weakened immune systems.
- HIV primarily infects and destroys immune cells with the CD4 receptor protein on their cell surfaces (also called CD4-positive or CD4+ T-cells). Healthy individuals have a CD4 cell count between 600 and 1,200 cells per microliter of blood. HIV patients have less than 600 CD4 cells per microliter of blood.
- Patients progress to AIDS when/if their CD4 cell counts drop to lower than 200 cells per microliter (one-one millionth of a liter) of blood. This may happen if a person does not receive adequate treatment or if he/she develops a serious infection or illness. Individuals with a CD4 cell counts lower than 200 have the greatest risk of developing potentially fatal opportunistic infections, such as Mycobacterium avium complex (MAC) infections, because their immune systems are very weak.
- HIV is transmitted from person to person via bodily fluids, including blood, semen, vaginal secretions, and breast milk. Therefore, it can be transmitted through sexual contact with an infected person, by sharing needles/syringes with someone who is infected, through breastfeeding, during vaginal birth, or, less commonly, through transfusions with infected blood. However, in countries where blood is screened for HIV antibodies, HIV infection is rarely transmitted through blood transfusions. Very low amounts of HIV have been found in saliva and tears in some AIDS patients. However, contact with saliva, tears, or sweat has not been shown to result in HIV transmission.
- The most common type of HIV worldwide is called HIV-1. It is easily transmitted and is the cause of most HIV/AIDS infections around the world. HIV-1 has several subtypes (A through H and O), which are more common in certain parts of the world but produce AIDS similarly. The second type, called HIV-2, is much less common and less virulent or infectious.
- Since 1981, when the first case of AIDS was reported in the United States, the disease has become a global pandemic, causing an estimated 65 million infections and 25 million
- During the mid-to-late 1990s, advances in HIV treatment slowed the progression of HIV infection to AIDS. This consequently led to decreases in AIDS-related deaths. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of AIDS-related deaths continues to decline, with an eight percent decrease from 2000 through 2004. However, the number of AIDS diagnoses increased eight percent during that period as well.
- From 2000 to 2004, the estimated number of people living with AIDS increased from 320,177 to 415,193, according to the CDC. This 30% increase can partially be attributed to advanced treatments that have helped HIV/AIDS patients to live longer lives, as well as increased access to testing and information about the disease.
- According to the CDC, an estimated 2.8 million patients died from AIDS, 4.1 million people became infected with HIV, and 38.6 million were living with HIV worldwide in 2005. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS) and World Health Organization (WHO) 2006 AIDS Epidemic Update, an estimated 39.5 million people are currently living with HIV worldwide. It is also estimated that 4.3 million people became newly infected in 2006, with 2.8 million (65%) of these cases occurring in Sub-Saharan Africa. In 2006, 2.9 million people died from AIDS-related illnesses.
- Certain geographic regions, such as Sub-Saharan Africa and the Caribbean, have much higher rates of infection than others. Certain populations, such as Sub-Saharan women, men who have sex with men (MSM), prostitutes, and injection-drug users, are also at increased risk for HIV infection.
- Currently, there is no cure for HIV/AIDS. However, treatment with anti-HIV drugs, called antiretrovirals, may suppress the virus, which subsequently helps boost the immune system. Although these drugs may help patients live longer lives, they do not reduce the risk of transmitting the disease to someone else.
Signs and symptoms
- Early symptoms: Many patients are asymptomatic (experience no symptoms) when they first become infected with HIV. After one or two months, an estimated 80-90% of HIV patients develops flu-like symptoms, including, headache, fever, fatigue, and enlarged lymph nodes. These symptoms usually last about one week to one month and are often mistaken for another viral infection, such as the flu. Despite having minimal or no symptoms during this stage, individuals are very infectious because the virus is present in large quantities in bodily fluids.
- The most obvious sign of HIV infection is a decrease in the number of CD4 cells in the blood. These cells help fight against infection. HIV slowly kills these cells without causing symptoms. Even when the infected individual is asymptomatic, the virus is multiplying, infecting, and destroying cells in the immune system.
- Clinical latency symptoms: After the initial infection with HIV, more serious symptoms develop. This next stage of infection is called clinical latency. Once infected with HIV, it may take 10 or more years for more severe symptoms to appear in adults or up to two years in children who are born with HIV infection. The length of this asymptomatic period varies among individuals. Some people may start to experience more serious symptoms within a few weeks, while others may have no symptoms for several years. The virus can also hide within infected cells. Patients can transmit the virus to others during all stages of the disease.
- As the immune system continues to weaken, many symptoms appear, including inflamed lymph nodes (swollen glands) that may be enlarged for longer than three months. Other symptoms may include fatigue, weight loss, frequent fevers and sweats, persistent or frequent yeast infections (oral or vaginal), persistent skin rashes or flaky skin, pelvic inflammatory disease (PID) in women that does not respond well to treatment, and short-term memory loss.
- In addition, some individuals develop a painful nerve disease called shingles or frequent and severe herpes infections that cause sores to develop on the mouth, genitals, or anus. Infected children may be sick often or grow slowly (failure to thrive) because their immune systems are still developing.
- AIDS symptoms: Once the patient's CD4 T-cell count is less than 200 cells per microliter of blood, their condition has progressed to AIDS, the final stage of the disease. The first symptoms often include moderate and unexplained weight loss, frequent lung infections, and oral ulcerations (sores).
- Patients are vulnerable to opportunistic infections and tumors. Opportunistic infections and tumors may include tuberculosis, thrush, herpes viruses, shingles, Epstein-Barr virus, pneumonia, and a type of cancer called Kaposi's sarcoma (KS). In the last stages of AIDS, it is common for individuals to have cytomegalovirus or Mycobacterium avium complex (MAC) infections.
- General: HIV is diagnosed after HIV antibodies or HIV itself is detected in the patient's body. As soon as the virus enters the body, the immune system produces antibodies, which are proteins that detect foreign substances in the body, including infectious agents like HIV. The presence of HIV antibodies in the blood, oral fluid, or urine can be used to determine whether HIV is in the body. Blood tests are the most commonly used HIV tests.
- It may take some time for the immune system to produce enough antibodies for the antibody test to detect them. This time period, known as the "window period," varies among patients. Most people will develop detectable antibodies two to eight weeks after exposure, with the average being 25 days. However, some individuals might take longer to develop detectable antibodies. Of those infected with HIV, 97% develop antibodies within the first three months of infection. In very rare cases, it can take up to six months to develop antibodies to HIV. Therefore, if a patient tests negative for HIV in the first three months after possible exposure, repeat testing should be considered at least three months after the exposure.
- In the United States, the test results must remain confidential. Individuals who are younger than 18 years old can consent to or refuse to be tested for HIV, without the involvement of their legal guardians. Test results may not be released to the patient's legal guardian(s) without his/her consent.
- Who should get tested: The U.S. Centers for Disease Control (CDC) recommends that the following individuals get tested for HIV:
- Individuals between the ages of 13 and 64 should be tested annually.
- Individuals who have injected illegal drugs.
- Individuals who have had unprotected vaginal, anal, or oral sex.
- Individuals who have multiple or anonymous sexual partners.
- Individuals who have exchanged sex for drugs or money.
- Individuals who been diagnosed with or treated for hepatitis, tuberculosis (TB), or a sexually transmitted disease (STD), such as syphilis, gonorrhea, or chlamydia.
- Individuals who have come in direct contact with an HIV-infected person's blood.
- Individuals who have had unprotected sex with someone who meets any of the above stipulations.
- Pregnant women should be screened for HIV as part of regular prenatal tests.
- Pre-test counseling: According to the U.S. Centers for Disease Control and Prevention's (CDC) new guidelines for HIV testing, HIV prevention counseling is not required to accompany HIV screening. However, the CDC still recommends that patients receive information about HIV infection, transmission, and prevention. Patients should receive information about HIV testing and the meaning of test results. Healthcare providers should also tell the patient when to expect results and that confirmatory testing is necessary if the test result is positive. This is because it is possible for a false positive test result.
- The patient may receive information through a pamphlet, brochure, video, or a one-on-one meeting with a certified counselor. Patients who are tested with a rapid HIV test should have equal access to the same types of information.
- Prevention counseling: Prevention counseling is not mandatory, but it should be offered to all patients when they receive their test results. Counseling focuses on reducing the risks of HIV infection or transmission. The counselor makes a personalized detailed risk assessment of the patient. The counselor should also suggest behavior changes that may help reduce the patient's risk of developing or transmitting HIV. The counseling session is a chance to clear up any misconceptions or questions the patient may have about the disease.
- Enzyme-linked immunosorbent assay (ELISA): The most common HIV tests use blood to detect HIV infection. The enzyme-linked immunosorbent assay (ELISA) tests a patient's blood sample for antibodies. Oral fluid (not saliva), collected from the cheeks and gums, may also be used to perform an ELISA. Oral fluid ELISA tests are considered as sensitive as a blood test. A urine sample may also be used during an ELISA, but this is considered less accurate than a blood or oral fluid test. A positive (reactive) ELISA for all samples must be used with a follow-up (confirmatory) test, such as the Western blot test, to make a positive diagnosis. Although false negative or false positive results are extremely rare, they may occur if the patient has not yet developed antibodies to HIV or if a mistake was made at the laboratory. When used in combination with the confirmatory Western blot test, ELISA tests are 99.9% accurate.
- Western blot test: A Western blot test is typically used to confirm a positive HIV diagnosis. During the test, a small sample of blood is taken and it is used to detect HIV antibodies, not the HIV virus itself. The Western blot test separates the blood proteins and detects the specific proteins (called HIV antibodies) that indicate an HIV infection. The Western blot is used to confirm a positive ELISA, and the combined tests are 99.9% accurate.
- Polymerase chain reaction (PCR):
Polymerase chain reaction
(PCR) tests are used to detect HIV's genetic material, called RNA. These tests can be used to screen the donated blood supply and to detect very early infections before antibodies have been developed. This test may be performed just days or weeks after exposure to HIV. Although these tests are the most accurate, they are not performed as often as the other HIV tests because they are expensive and also time- and labor-intensive.
- Rapid test: A rapid test produces results in about 20 minutes. Rapid tests use a sample of blood or oral fluid to detect HIV antibodies. The patient's sample is placed on a test strip that contains HIV antigens. If the patient has developed HIV antibodies, the strip will change colors, indicating a positive result. A positive HIV test should be confirmed with a follow-up confirmatory test before a final HIV diagnosis can be made. These tests have similar accuracy rates as traditional ELISA screening tests.
- Home-testing kit:
Consumer-controlled test kits, also called home-testing kits, were first licensed in 1997. The Home Access HIV-1 Test SystemT is a home kit that is approved by the U.S. Food and Drug Administration (FDA). The Home Access HIV-1 Test SystemT is available at most local pharmacies. The individual pricks a finger with a special device and places drops of blood on a specially treated card. The card is then mailed to a licensed laboratory for testing. Home testing kits are confidential, and patients do not need to provide any personal information (such as name or address) when submitting samples. Instead, they call for results using a personal identification number (PIN). Callers may speak to a counselor any time before, during, or after the test. All individuals with positive test results are given referrals for follow-up confirmatory tests, as well as information and resources on treatment and support services. FDA-approved tests are equally as accurate as the tests performed in a doctor's office when performed correctly.
- HIV drug resistance testing:
Drug resistance testing is used to determine whether a patient with HIV has a mutated form of the virus that does not respond to antiretroviral therapy (ART).
- If an HIV-infected patient becomes resistant to a drug and continues to take the same medication, HIV is able to multiply faster because the drug cannot stop it from replicating. When the new, mutated form is favored, it is called selective pressure. If the resistant virus makes enough copies of itself, it may eventually become the dominant type of HIV in the body. Once this happens, the medication is ineffective, and the patient will be resistant to the specific medication.
- The FDA has approved the drug resistance test TrueGeneT. The sensitivity, specificity, and reproducibility for many other tests have not been well established. However, several tests are available, and many health insurance plans cover them.
There are two main types of drug resistance tests: genotypic and phenotypic resistance tests.
- Genotypic resistance testing examines the genetic structure (genotype) of a patient's HIV. A blood sample is taken from the patient, and the HIV is analyzed for the presence of specific genetic mutations that are known to cause resistance to specific drugs. For instance, researchers have determined that lamivudine (Epivir®) and emtricitabine (Emtriva®) are not effective against forms of HIV that contain the mutation "M184V" in its reverse transcriptase gene. If a patient tests positive for this mutation, it is highly likely that he or she is resistant to both drugs, and different drugs should be prescribed.
- Phenotypic testing directly measures the sensitivity (phenotype) of a patient's HIV in response to specific antiretrovirals. Many experts believe that these tests are more accurate and comprehensive than genotypic tests. These tests can help a physician determine the amount or concentration of a drug that is needed to stop a specific strain of HIV from replicating in a patient.
- Genetic testing: Genetic testing can be done on several genes that affect HIV and the course of the infection. For example, a genetic mutation causing a protein defect called CCR5 delta 32 has been shown to be resistant to the HIV virus. Mutations in the major histocompatibility complex, class I, B (HLA-B) gene is also linked to the HIV virus. There are several variations in HLA-B that can either slow the progression of HIV to AIDS or speed it up. Mutations in the killer cell immunoglobulin-like receptor, three domains, long cytoplasmic tail, 1(KIR3DL1) gene and the chemokine (C-C motif) ligand 3-like 1 (CCL3L1) gene have also been associated with varying rates of AIDS progression.
- Opportunistic infections:
- General: Opportunistic infections are conditions that occur in individuals who have weakened immune systems. The organisms (bacteria, fungi, or viruses) that cause these infections do not cause illnesses in patients who have healthy immune systems because they are able to fight off the infection. The most common opportunistic infections associated with HIV and AIDS are Pneumocystis jiroveci pneumonia, Mycobacterium avium complex (MAC), toxoplasmosis, and tuberculosis. Patients at risk of developing these infections typically receive medication to prevent infections.
- Pneumocystis jiroveci pneumonia: Pneumocystis jiroveci pneumonia (formerly called Pneumocystis carinii or PCP) is the most common opportunistic infection among HIV patients. Before antiretroviral therapy and preventative treatment was available, about 70-80% of people with HIV developed PCP. However, this number has been declining significantly over the years.
- Originally, researchers thought a one-cell organism called Pneumocystis carinii caused the infection. However, recent research suggests that a fungus called Pneumocystis jiroveci is the cause. The condition is still commonly referred to as Pneumocystis carinii pneumonia (PCP).
- According to the U.S. Centers for Disease Control and Prevention (CDC), PCP is classified as an AIDS-defining illness. This means that when HIV-infected patients develop PCP, their condition has progressed to AIDS. Individuals with a CD4 cell (helper T-cells that help fight against disease and infection) count lower than 200 cells per microliter of blood have the greatest risk of developing PCP. In addition, people who have CD4 cell counts lower than 300 who have already had another opportunistic infection have an increased risk of developing PCP.
- This infection almost always affects the lungs causing a type of pneumonia. The first signs of PCP are difficulty breathing, fever, and a dry cough. Other common symptoms include chest discomfort, weight loss, chills, tachypnea (rapid breathing), tachycardia (fast heart rate), mild crackles (bubbling or rattling sounds that occur when air moves through fluid-filled airways), cyanosis (bluish discoloration of the skin), nasal flaring, and intercostal retractions (visible use of muscles between the ribs, which indicates labored breathing). The patient may also cough up blood, although this is considered a rare symptom.
- Historically, mortality ranged from 20-40%, depending on the severity of the disease when it was diagnosed. Today, however, mortality rates range between 10-20%.
- Today, PCP is almost entirely preventable, and it can be treated effectively with medications. Unfortunately, PCP is still common in patients who are infected with HIV for a long time before they begin antiretroviral therapy (ART). In fact, 30-40% of HIV patients develop PCP if they begin treatment when their CD4 cell counts are very low (around 50 cells per microliter of blood).
- Mycobacterium avium complex (MAC): Mycobacterium avium complex (MAC), or mycobacterium avium intracellulare (MAI), is a bacterial infection that is caused by either Mycobacterium avium or Mycobacterium intracellulare. These bacteria are commonly found in water, soil, dust, and food. In fact, these bacteria are present in almost every human. However, a healthy immune system prevents the bacteria from causing an infection. HIV/AIDS patients are at risk of developing MAC.
- According to the CDC, MAC is considered an AIDS-defining illness. It is estimated that up to 50% of individuals with HIV/AIDS develop MAC, especially if their CD4 count is lower than 50 cells per microliter of blood. MAC rarely causes infections in patients who have CD4 cell counts higher than 100 cells per microliter of blood.
- MAC infections may be localized (limited to one part of the body) or disseminated (spread throughout the entire body, sometimes called DMAC). MAC infection often occurs in the lungs, intestines, bone marrow, liver, and spleen.
- Common symptoms of MAC include weight loss, fever, chills, night sweats, swollen glands, abdominal pain, diarrhea, inflammation, and an overall feeling of weakness. MAC usually affects the intestines and inner organs first.
- The most common complication of DMAC is anemia (low levels of red blood cells), which may require a blood transfusion. If the infection involves many organs, it may lead to respiratory failure and death. Patients who have localized infections that have not spread to other parts of the body have a low mortality rate because they are easier to treat.
- Toxoplasmosis: Toxoplasmosis (toxo) is a parasitic infection that is caused by a single-celled parasite called Toxoplasma gondii.
- Toxoplasma gondii is one of the most common parasites, found all over the world. Individuals may be exposed to the parasite in soil, cat feces, or in raw or undercooked meat (especially lamb, pork, or venison). There have also been rare reports of toxoplasmosis infection as a result of organ transplantation or blood transfusion.
- It is estimated that more than 60 million Americans carry the parasite. However, 80-90% of infected patients are carriers (experience no symptoms) because the body's immune system prevents the parasite from causing illness. Toxoplasmosis is considered an AIDS-defining illness, according to the CDC.
- HIV patients often experience symptoms such as headache, confusion, poor coordination, seizures, and ocular toxoplasmosis (severe inflammation of the retina) as well as lung problems that are similar to tuberculosis or pneumocystis pneumonia.
- Tuberculosis: Tuberculosis (TB) is a bacterial infection of the lungs, which is caused by the bacterium Mycobacterium tuberculosis. Symptoms may include cough, shortness of breath, pleurisy (pain with breathing or coughing), fever, weight loss, night sweats, chills, and loss of appetite. The disease can cause serious breathing problems, which can be life threatening, especially if left untreated.
- Tuberculosis is highly contagious. The disease is transmitted through airborne droplets when a person with the infection coughs, talks, or sneezes.
- About 10-15 million Americans have latent TB infection, which means they are not sick, but they carry the bacterium that causes the disease. Only 10% of individuals with latent TB ever develop the infection.
- While tuberculosis is not considered an AIDS-defining illness, HIV patients have an increased risk of developing TB because they have weakened immune systems. The risk of developing active TB increases 7-10% in HIV patients who have latent TB. HIV patients are more likely to experience symptoms in areas of the body other than the lungs. This is called extrapulmonary TB. The disease may affect the bones, joints, nervous system, or urinary tract. Also, TB appears to make HIV infection worse; researchers have observed faster HIV replication when tuberculosis is also present.
- HIV and pregnancy:
- Babies born to HIV-infected mothers may become infected during pregnancy, delivery, or breastfeeding. Therefore, the U.S. Centers for Disease Control and Prevention (CDC) recommend that all pregnant women get tested for HIV.
- Antiretroviral therapy can significantly reduce the likelihood of an HIV-infected pregnant mother passing the virus to her baby. Patients who were taking antiretroviral medication before becoming pregnant should talk to their healthcare providers to determine the safest and most effective treatment option. In general, efavirenz (Sustiva®), stavudine (Zerit®), hydroxyurea (Droxia® or Hydrea®), and the oral liquid formulation of amprenavir (Agenerase®) should not be taken during pregnancy because they may cause harm to the fetus.
- Because a baby may become infected though exposure to the mother's blood and vaginal secretions during delivery, the risk of infection increases with delivery time. Mothers with high levels of the virus in their blood might reduce their risk if they deliver their babies by cesarean section (surgical delivery of an infant), also called c-section. While c-sections may reduce the risk of transmission during birth, it is not typically necessary in patients taking antiretroviral therapy.
- HIV infection rates of babies shortly before or after birth have been shown to drop to as low as 1-2% if their mothers take combination antiretroviral therapy during pregnancy, as well as zidovudine or nevirapine (Viramune®) preventative therapy during labor and after birth.
- HIV-infected mothers should not breastfeed their babies because the virus may be transmitted via the breast milk. Instead, baby formulas should be used.
- General: Although current antiretroviral drugs cannot cure HIV/AIDS, they may suppress the virus, even to undetectable levels. The guidelines for antiretroviral treatment are the same for adolescents and adults.
- In emergency situations, or if parental involvement is impossible or could cause harm, and if the patient can adhere to treatment regimens, a minor can consent to treatment without parental involvement. However, communication with legal guardians should be encouraged in all patients who are younger than 18 years old and need to make healthcare decisions.
- Patients who were taking antiretroviral medication before becoming pregnant should talk to their healthcare providers to determine the safest and most effective treatment options. In general, efavirenz (Sustiva®), stavudine (Zerit®), hydroxyurea (Droxia® or Hydrea®), and the oral liquid formulation of amprenavir (Agenerase®) should not be taken during pregnancy because they may cause harm to the fetus.
- Highly active antiretroviral therapy (HAART): HIV patients typically receive a combination of antiretroviral drugs because a single patient may have several different strains (types) of the virus circulating in the blood. The different strains of the virus may respond differently to specific types of drugs. Therefore, highly active antiretroviral therapy (HAART), which is a combination of drugs from at least two different drug classes, is recommended. There are five major classes of antiretrovirals: fusion inhibitors, nucleoside/neucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors, and integrase inhibitors. Each drug class disrupts different stages of HIV's life cycle.
- Fusion inhibitors prevent the virus from entering and infecting human cells. The U.S. Food and Drug Administration (FDA) has approved the fusion inhibitor, enfuvirtide (Fuzeon®), also called T-20. Clinical trials have demonstrated that enfuvirtide-based therapy is an effective treatment for patients who have taken other types of antiretrovirals in the past. Enfuvirtide should not be taken in patients who have never received antiretroviral drugs before because it is only recommended when other drugs have not worked.
- Nucleoside reverse transcriptase inhibitors (NRTIs) and nucleotide reverse transcriptase inhibitors (NtRTIs), also called nukes, inhibit HIV replication. HIV replicates by converting the viral RNA into complementary DNA (cDNA), which then integrates into the host DNA. A viral enzyme called reverse transcriptase (RT) converts the viral RNA into cDNA using host nucleotides, which are the building blocks of DNA. NRTIs are nucleoside analogs, or fake versions of nucleosides (which are the precursors to nucleotides), and the resulting DNA cannot be incorporated into the host DNA. NtRTIs are neucleotide analogs and do not need to be converted. Therefore, NtRTIs may have fewer side effects than NRTIs. The FDA has approved the following NRTIs: lamivudine/zidovudine (Combivir®), emtricitabine (Emtriva®), lamivudine (Epivir®), abacavir sulfate/lamivudine
(Epzicom®), zalcitabine (Hivid®), zidovudine (Retrovir®), abacavir sulfate/lamivudine/zidovudine
(Trizivir®), emtricitabine/tenofovir disoproxil fumarate (Truvada®), didanosine (Videx®, Videx EC®), stavudine (Zerit®), and abacavir sulfate (Ziagen®). Tenofovir disoproxil fumarate (Viread®) is an FDA-approved NtRTI.
- Non-nucleoside reverse transcriptase inhibitors (NNRTIs), also called non-nucleoside analogs, interfere with viral replication. HIV replication requires the enzyme reverse transcriptase (RT), which is targeted by NNRTIs. When patients take non-nucleoside reverse transcriptase inhibitors (NNRTIs), the drug attaches to HIV's enzyme before it can use the patient's nucleic acid to multiply. NNRTIs significantly reduce the ability of HIV to multiply and infect new cells. The FDA has approved several NNRTIs, including delavirdine (Rescriptor®), efavirenz (Sustiva®), and nevirapine (Viramune®). Also, in July 2006, the FDA approved the multi-class combination drug efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla®), which includes one NNRTI and two NRTIs.
- Protease inhibitors (PIs) also interfere with HIV replication, they prevent the production of viral proteins that require an enzyme called protease. When protease is blocked, the new copies of HIV do not form properly and cannot infect new cells. The FDA has approved several protease inhibitors including: amprenavir (Agenerase®), tipranavir (Aptivus®), indinavir (Crixivan®), saquinavir mesylate (Invirase®), opinavir/ritonavir (Kaletra®), fosamprenavir calcium (Lexiva®), ritonavir (Norvir®), darunavir (Prezista®), atazanavir sulfate (Reyataz®), and nelfinavir mesylate (Viracept®).
- In October 2007, the FDA approved an integrase inhibitor, called raltegravir (Isentress®), for the treatment of HIV in combination with other antiretrovirals. Integrase inhibitors are a new class of antiretrovirals that block the integrase enzyme that HIV uses to incorporate cDNA into host DNA.
- Antiretroviral side effects: Individuals taking antiretroviral drugs often find it difficult to follow complicated drug plans. Current treatments involve taking at least two different classes of antiretroviral drugs daily. Also, some of the drugs may cause nausea or vomiting, some pills should be taken on an empty stomach, and others should be taken with food. Specific side effects depend on the specific drugs. In general, common side effects include changes in body fat distribution and blood lipid levels. Glucose metabolism (the breakdown of carbohydrates to produce energy) is also affected, which may lead to the onset or worsening of diabetes. It is estimated that about 2-10% of people taking antiretrovirals have diabetes.
- The National Institute of Allergy and Infectious Diseases is among many research organizations that is investigating simpler, less toxic, and more effective drug plans.
- Synergistic enhancers: Another group of medications, called synergistic enhancers, may also be used in combination with other antiretroviral drugs to treat HIV. These medications do not act as antiretrovirals when taken alone, but they have been shown to improve the antiretrovirals effects of other drugs, including ritonavir. Very small doses of synergistic enhancers may also be used to reduce the liver metabolism of other antiretroviral drugs.
- Surgery: Patients infected with the human immunodeficiency virus (HIV) may require surgery to treat infections and diseases associated with the condition. With the introduction of HAART, HIV patients are able to live longer lives. As a result, it is possible that surgical interventions may be needed to diagnoses and/or treat long-term conditions. For example, lung infections, which may be caused by Pneumocystis jiroveci pneumonia (formerly called Pneumocystis carinii pneumonia, PCP), Mycobacterium avium complex (MAC), and tuberculosis often require invasive diagnostic procedures, such as bronchoalveolar lavage or an open lung biopsy. Like any surgical procedure, there are potential health risks. It remains unclear whether HIV patients are more likely to develop complications than HIV-negative patients.
- Common complications of surgery include bleeding, infections, and nerve damage. It has been suggested that HIV patients may have an increased risk of surgical complications (especially infections) because they have weakened immune systems. However, there is currently no scientific data on the prevalence of surgical complications among HIV patients compared to non-infected patients.
- Researchers believe that the risks of surgical complications for HIV patients can be predicted in a way similar to the method used in HIV-negative patients. Prior to surgery, healthcare providers should perform a physical examination, detailed medical history, and laboratory testing to determine the patient's overall health. Healthcare providers must also consider possible interactions between the patient's anti-HIV drugs (antiretrovirals) and medications, such as pain relievers, that are used before, during, and after surgical procedures.
- It remains unclear whether a patient's CD4 cell count influences their risk of surgical complications. Healthy individuals have a CD4 cell count between 600 and 1,200 cells per microliter of blood. The lower the CD4 count, the weaker the patient's immune system. Some studies have found no correlation between low CD4 cell counts and surgical complications, while others have found an increase in complications with lower CD4 counts. Further research is needed before a firm conclusion can be made.
- Organ transplants: As mentioned above, HAART enables HIV/AIDS patients to live longer lives. Today, most patients with HIV/AIDS are dying from end-stage organ disease and organ failure rather than AIDS-associated opportunistic infections. Since HAART prolongs the lives of HIV patients, it is possible for chronic conditions to progress to organ failure. For instance, HIV patients may experience end-stage liver disease as a complication of chronic hepatitis C virus. Glomeruli diseases are also common among HIV patients, and they may lead to kidney failure. In advanced stages of liver or kidney damage, organ transplants may be the patient's only chance of survival.
- Until recently, people who had HIV were not considered good candidates for organ transplantations. Many patients were denied transplants under the assumption that they had shorter life expectancies and less favorable survival rates than other patients in need of transplants. However, now that patients are living longer lives, many groups are re-considering whether HIV patients should be transplant candidates.
- Although the United Network for Organ Sharing (UNOS) does not consider HIV infection a contraindication for organ transplantation, individual transplant centers are in charge of deciding whether or not to perform surgery in an HIV-positive patient. Some centers will not provide organ transplants to HIV-positive patients, even if they are good candidates based on their physical and mental health.
- Some health insurance companies are reluctant to cover transplantation in HIV-positive candidates because they consider it to be an experimental procedure. Currently, only a few medical centers worldwide perform organ transplants in HIV-positive patients. However, health insurance companies and doctors consider organ transplantations in HIV-negative patients to be a well-established, reimbursable procedure.
- Recent legislation in California and a ruling in Arizona may help increase HIV patients' access to transplant surgery. In October 2005, an administrative law judge declared that Medicaid had to pay for a liver transplant for an Arizona woman who was HIV-positive. In the same month, California Governor Arnold Schwarzenegger signed a law that prohibits health insurance companies from denying coverage for organ transplants in HIV patients solely on the basis of their HIV-status. The law is the first of its kind to target such denials.
- The limited number of transplants that have been performed in HIV patients have produced encouraging results. However, organ transplants for people with HIV/AIDS have not gained widespread medical support, and there are still concerns regarding the long-term prognosis for HIV-positive transplant recipients.
- Treatment adherence: In order for anti-HIV drugs to work correctly, they must be taken exactly as prescribed. Skipping doses or not taking the medications correctly can cause the amount of an antiretroviral drug to decrease in the bloodstream. If the drug level becomes too low, HIV can begin reproducing more quickly. The faster HIV reproduces, the more mutations occur, including those that may be resistant to drugs.
When a patient becomes resistant to a drug, the medication is no longer effective, even if it is taken in the future. As a result, patients have fewer treatment options.
- According to several studies, HIV patients must be more than 95% adherent to their treatment plans in order for them to remain effective. This means that missing more than one dose per month may reduce the drugs' effectiveness.
- Healthcare providers evaluate treatment effectiveness by measuring CD4 cell counts in the patient's blood. These immune cells are the primary targets of HIV. If the CD4 cell count is maintained, the likelihood of the virus mutating into resistant strains is decreased. HIV patients who are otherwise healthy and symptom-free should have their CD4 cell count and viral load tested about 2-4 times a year. However, symptomatic patients should be tested more frequently to evaluate both the risk of opportunistic infections and the response to HIV drug treatments.
- Note: Integrative therapies should not replace antiretroviral therapy (ART) in HIV patients. Patients should consult their healthcare providers before taking any herbs or supplements because they may interact with treatment. In particular, patients should not take St. John's wort because it may interact with HIV treatment.
- Unclear or conflicting scientific evidence:
- Aloe vera:
Clear gel from the pulp of Aloe vera leaves has been used on the skin for thousands of years to treat wounds, skin infections, minor burns, and other skin conditions. Although aloe has been suggested as a possible treatment for HIV infection, further research is needed before a firm conclusion can be made.
- Avoid if allergic to aloe or other plants of the Liliaceae family (garlic, onions, and tulips). Avoid injecting aloe. Do not apply to open skin, surgical wounds, or pressure ulcers. Avoid taking by mouth with diarrhea, bowel blockage, intestinal diseases, bloody stools, or hepatitis. Avoid with a history of irregular heartbeat (arrhythmia), electrolyte imbalances, diabetes, heart disease, or kidney disease. Avoid taking by mouth if pregnant or breastfeeding.
- Alizarin: Limited available evidence suggests that alizarin may be of benefit in the treatment of viral infections. Additional research is needed in this area.
- Avoid if allergic or hypersensitive to alizarin or any plants in the Rubiaceae family. Alizarin may be toxic and should not be handled for long periods of time, rubbed in the eyes, or eaten. Avoid if pregnant or breastfeeding.
Antineoplastons are substances found in human blood and urine. Preliminary study reported increased energy and weight in patients with HIV who were treated with antineoplaston AS2-1, as well as a decreased number of opportunistic infections and increased CD4 cell counts. However, this evidence cannot be considered conclusive. Currently, there are drug therapy regimens available for HIV with clearly demonstrated effects (highly active anti-retroviral therapy), and patients with HIV are recommended to consult with their physicians about treatment options.
- Avoid if allergic or hypersensitive to antineoplastons. Use cautiously with high medical or psychiatric risk. Use cautiously with an active infection due to a possible decrease in white blood cells. Use cautiously with high blood pressure, heart conditions, chronic obstructive pulmonary disease, liver disease/damage, or kidney disease/damage. Avoid if pregnant or breastfeeding.
- Astragalus: Antiviral effects have been reported in early studies for HIV. Additional research is warranted.
- Avoid if allergic to astragalus, peas, or any related plants or with a history of Quillaja bark-induced asthma. Avoid with aspirin or aspirin products or herbs or supplements with similar effects. Avoid with inflammation (swelling) or fever, stroke, transplant or autoimmune diseases (like HIV/AIDS). Stop use two weeks before surgery/dental/diagnostic procedures with a risk of bleeding and avoid use immediately after these procedures. Use cautiously with bleeding disorders, diabetes, high blood pressure, lipid disorders or kidney disorders. Use cautiously with blood-thinners, blood sugar drugs, or diuretics or herbs and supplements with similar effects. Avoid if pregnant or breastfeeding.
- Beta sitosterol: Beta-sitosterol is found in plant-based foods, such as fruits, vegetables, soybeans, breads, peanuts, and peanut products. It is also found in bourbon and oils (such as olive oil, flaxseed, and tuna). Due to data that suggest immune modulating effects of beta-sitosterol and beta-sitosterol glucoside, these sterols have been studied in combination in the treatment of HIV. Larger populations of patients with HIV should be evaluated in randomized controlled trials to draw any conclusions.
- Avoid if allergic or hypersensitive to beta-sitosterol, beta-sitosterol glucoside, or pine. Use cautiously with asthma or breathing disorders, diabetes, primary biliary cirrhosis (destruction of the small bile duct in the liver), ileostomy, neurodegenerative disorders (like Parkinson's disease or Alzheimer's disease), diverticular disease (bulging of the colon), short bowel syndrome, celiac disease, and sitosterolemia. Use cautiously with a history of gallstones. Avoid if pregnant or breastfeeding.
- Bitter melon: Laboratory studies have shown that a protein in bitter melon called MAP30 may have antiviral activity against HIV. However, this has not been studied in humans. Further research is needed before a firm conclusion can be made.
- Avoid if allergic to bitter melon or members of the Curcurbitaceae (gourd or melon) family. Avoid ingesting bitter melon seeds. Avoid with glucose-6-phosphate dehydrogenase deficiency. Use cautiously with diabetes, glucose intolerance, or with hypoglycemic agents due to the risk of hypoglycemia (low blood sugar). Avoid if pregnant or breastfeeding.
- Blessed thistle: Laboratory studies report no activity of blessed thistle against herpes viruses, influenza, or poliovirus. Effects of blessed thistle (or chemicals in blessed thistle called lignans) against HIV are not clear. Human research of blessed thistle as a treatment for viral infections is lacking.
- Blessed thistle is generally considered to be safe when taken by mouth in recommended doses for short periods of time, with few reported side effects such as birth defects, bleeding, breathing problems, bruising, cancer of the nose or throat, increased production of stomach acid, itching, kidney disease, liver toxicity, skin rash, stomach discomfort, stomach ulcers, and vomiting. Allergic reactions to blessed thistle including rash may occur, as well as cross-sensitivity to mugwort and Echinacea. Cross-reactivity may also occur with bitter weed, blanket flower, Chrysanthemum, coltsfoot, daisy, dandelion, dwarf sunflower, goldenrod, marigold, prairie sage, ragweed or other plants in the Asteraceae/Compositae family. Avoid if pregnant or breastfeeding.
- Boxwood: Trials have been conducted for SPV30 (extract of boxwood, Arkopharma, France) to evaluate its potential effectiveness for HIV/AIDS. Rigorous clinical study is needed to confirm these early study results.
- Avoid if allergic or hypersensitive to boxwood, its constituents, or any plants in the Buxaceae family. Use cautiously with HIV or AIDS. Avoid if pregnant or breastfeeding.
- Carrageenan: Carrageenan-based gels may reduce HIV transmission during sexual intercourse and have been investigated for safety and acceptability in published studies involving healthy females. Overall, studies suggest that carrageenan is not associated with abnormal genital clinical findings or severe side effects, and is considered acceptable for use by females and their male partners. Additional research is needed to better determine the role of carrageenan for HIV infection prevention.
- Use oral carrageenan cautiously in infants. Use cautiously in patients with, or at risk for, cancer. Use cautiously in patients treated with azoxymethane or nitrosomethylurea. Use cautiously in patients with gastrointestinal, immune, inflammatory, or bleeding disorders, or in patients with low blood pressure or diabetes. Use cautiously intravaginally. Use cautiously in patients using antilipemic agents. Use cautiously in combination with any oral medication, as the fiber in carrageenan may impair the absorption of oral medications.
- Chiropractic: Chiropractic care focuses on how the relationship between musculoskeletal structure (mainly the spine) and bodily function (mainly nervous system) affects health. There is currently not enough reliable scientific evidence to conclude the effects of chiropractic techniques on CD4 cell count or quality of life in patients with HIV/AIDS.
- Use extra caution during cervical adjustments. Use cautiously with acute arthritis, conditions that cause decreased bone mineralization, brittle bone disease, bone softening conditions, bleeding disorders or migraines. Use cautiously with the risk of tumors or cancers. Avoid with symptoms of vertebrobasilar vascular insufficiency, aneurysms, unstable spondylolisthesis, or arthritis. Avoid with agents that increase the risk of bleeding. Avoid in areas of para-spinal tissue after surgery. Avoid if pregnant or breastfeeding due to a lack of scientific data.
- Coenzyme Q10:
Coenzyme Q10 (CoQ10) is produced by the body and it is necessary for basic functioning of cells. CoQ10 levels decrease with age. There is limited evidence that natural levels of CoQ10 in the body may be reduced in people with HIV/AIDS. Reliable scientific research showing that CoQ10 supplements have any effect on this disease is currently lacking.
- There are currently no documented cases of allergy associated with Coenzyme Q10 supplements, although rash and itching have rarely been reported. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk and do not use immediately after these procedures. Use cautiously with history of blood clots, diabetes, high blood pressure, heart attack, or stroke. Use cautiously with anticoagulants (blood thinners), antiplatelet drugs, blood pressure drugs, blood sugar drugs, cholesterol drugs, or thyroid drugs. Avoid if pregnant or breastfeeding.
- Cranberry: Limited laboratory research has examined the antiviral activity of cranberry. Further research is warranted in this area.
- Avoid if allergic to cranberries, blueberries, or other plants of the Vaccinium species. Sweetened cranberry juice may affect blood sugar levels. Use cautiously with a history of kidney stones. Pregnant and breastfeeding women should avoid cranberry in higher amounts than what is typically found in foods.
DHEA (dehydroepiandrosterone) is a hormone that is secreted by the adrenal glands. Although some studies suggest that DHEA supplementation may be beneficial in patents with HIV, results from different studies do not agree with each other. There is currently not enough scientific evidence to recommend DHEA for AIDS, and other therapies are more proven in this area.
- Avoid if allergic to DHEA. Avoid with a history of seizures. Use cautiously with adrenal or thyroid disorders. Use cautiously if taking anticoagulants, or drugs, herbs, or supplements for diabetes, heart disease, seizures, or stroke. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk, and do not use immediately after these procedures. Avoid if pregnant or breastfeeding.
- Flaxseed and flaxseed oil:
Flaxseed and flaxseed oil/linseed oil are rich sources of the essential fatty acid, alpha-linolenic acid (omega-6). While flaxseed has been used to treat HIV/AIDS, no strong evidence supports its use and no recommendation can be made without further research.
- Flaxseed has been well tolerated in studies for up to four months. Avoid if allergic to flaxseed, flaxseed oil, or other plants of the Linaceae family. Avoid with prostrate cancer, breast cancer, uterine cancer, or endometriosis. Avoid ingestion of immature flaxseed pods. Avoid large amounts of flaxseed by mouth and mix plenty of water or liquid. Avoid flaxseed (not flaxseed oil) with history of esophageal stricture, ileus, gastrointestinal stricture, or bowel obstruction. Avoid with history of acute or chronic diarrhea, irritable bowel syndrome (IBS), diverticulitis (inflammation of the diverticula, small sacs in the intestine's inner lining), or inflammatory bowel disease (IBD). Avoid topical flaxseed in open wounds or abraded skin surfaces. Use cautiously with history of a bleeding disorder or with drugs that increase the risk of bleeding (such as anticoagulants and non-steroidal anti-inflammatories). Use cautiously with high triglyceride levels, diabetes, mania, seizures, or asthma. Avoid if pregnant or breastfeeding.
- Green tea: Green tea is made from the dried leaves of Camellia sinensis, a perennial evergreen shrub. Green tea has a long history of use, dating back to China approximately 5,000 years ago. Green tea, black tea, and oolong tea are all derived from the same plant. Preliminary research suggests that green tea may decrease viral load in carriers of the human T-cell lymphocytic virus. Additional well-designed controlled research is needed before a conclusion can be made.
- Avoid if allergic or hypersensitive to caffeine or tannins. Use cautiously with diabetes or liver disease.
- Healing Touch: Healing touch (HT) is a combination of hands-on and off-body techniques that influence the flow of energy through a person's biofield. Data from small preliminary studies are insufficient to support any recommendations for or against use of HT in HIV/AIDS patients. Studies of better design are needed before any conclusions can be reached.
- HT should not be regarded as a substitute for established medical treatments. Use cautiously if pregnant or breastfeeding.
- L-carnitine: L-carnitine may be beneficial in AIDS treatment by increasing proliferation of mononuclear cells and increasing CD4 counts. Additional study is needed to make a firm recommendation.
- Avoid if allergic or hypersensitive to carnitine. Use cautiously with peripheral vascular disease, high blood pressure, alcohol-induced liver cirrhosis, and diabetes. Use cautiously in low birth weight infants and individuals on hemodialysis. Use cautiously if taking anticoagulants (blood thinners), beta-blockers, or calcium channel blockers. Avoid if pregnant or breastfeeding.
- Licorice: Early studies suggest that glycyrrhizin may inhibit HIV replication in patients with AIDS. However, human reports are lacking. Additional study is needed to make a conclusion.
- Avoid with a known allergy to licorice, any component of licorice, or any member of the Fabaceae (Leguminosae) plant family. Avoid with congestive heart failure, coronary heart disease, kidney or liver disease, fluid retention, high blood pressure, hormonal abnormalities or with use of diuretics. Licorice can cause abnormally low testosterone levels in men or high prolactin or estrogen levels in women. This may make it difficult to become pregnant and may cause menstrual abnormalities.
- Massage: Evidence is limited and mixed as to whether massage may be of benefit for immune functioning or health services utilization in people with HIV/AIDS.
- Avoid with bleeding disorders, low platelet counts, or if on blood-thinning medications (such as heparin or warfarin/Coumadin®). Areas should not be massaged where there are fractures, weakened bones from osteoporosis or cancer, open/healing skin wounds, skin infections, recent surgery, or blood clots. Use cautiously with history of physical abuse or if pregnant or breastfeeding. Massage should not be used as a substitute for more proven therapies for medical conditions. Massage should not cause pain to the client.
- Meditation: Various forms of meditation have been practiced for thousands of years throughout the world, with many techniques originating in Eastern religious practices. A common goal is to attain a state of "thoughtless awareness" of sensations and mental activities occurring at the present moment. More studies are needed to establish how meditation may be useful as an adjunctive therapy in HIV/AIDS patients.
- Use cautiously with underlying mental illnesses. People with psychiatric disorders should consult with their primary mental healthcare professionals before starting a program of meditation and they should explore how meditation may or may not fit in with their current treatment plans. Avoid with risk of seizures. The practice of meditation should not delay the time to diagnosis or treatment with more proven techniques or therapies, and it should not be used as the sole approach to illnesses.
- Melatonin: Melatonin is a neurohormone produced in the brain. There is a lack of well-designed scientific evidence to recommend for or against the use of melatonin as a treatment for AIDS. Melatonin should not be used in place of more proven therapies, and patients with HIV/AIDS should be treated under the supervision of their healthcare professionals.
- Based on available studies and clinical use, melatonin is generally regarded as safe in recommended doses for short-term use. There are rare reports of allergic skin reactions after taking melatonin by mouth. Use cautiously with bleeding disorders, seizure disorders, or if taking drugs that increase the risk of bleeding.
- Mistletoe: Treatment of HIV patients with mistletoe has been conducted in Europe since the beginning of the AIDS epidemic. Treatment seems to be tolerable with minimal side effects reported. Mistletoe may assist in inhibiting disease progression. However, not all mistletoe preparations have shown equal effects. Further study is needed before a firm conclusion can be made.
- Avoid if allergic or hypersensitive to mistletoe or to any of its constituents. Anaphylactic reactions (life threatening, shock) have been described after injections of mistletoe. Avoid with acute, highly febrile, inflammatory disease, thyroid disorders, seizure disorders, or heart disease. Use cautiously with diabetes, glaucoma, or with cholinergics.
- Prayer/distant healing: Prayer can be defined as a "reverent petition," the act of asking for something while aiming to connect with God or another object of worship. Limited study of prayer in patients with HIV/AIDS reports fewer new AIDS-related illnesses and hospitalizations. However, due to methodological problems, these results cannot be considered conclusive.
- Prayer is not recommended as the sole treatment approach for potentially serious medical conditions, and it should not delay the time it takes to consult with a healthcare professional or receive established therapies. Sometimes religious beliefs come into conflict with standard medical approaches and require an open dialog between patients and caregivers.
- Psychotherapy: Psychotherapy is an interactive process between a person and a qualified mental health professional. The patient will explore thoughts, feelings, and behaviors to help with problem solving. Psychotherapy, especially supportive psychotherapy, may reduce depression in HIV-positive patients. It may also help with treating substance abuse when used in combination with prescription medicine. Supportive-expressive group therapy may also have concomitant improvements in CD4 cell count and viral load. More research is needed in this area, especially to determine the best type of psychotherapy.
- Psychotherapy cannot always fix mental or emotional conditions. Psychiatric drugs are sometimes needed. In some cases, symptoms may get worse if the proper medication is not taken. Not all therapists are qualified to work with all problems. Use cautiously with serious mental illness or some medical conditions because some forms of psychotherapy may stir up strong emotional feelings and expression.
- Reiki: Reiki instruction may help reduce pain or anxiety in HIV/AIDS patients, but results are unclear.
- Reiki is not recommended as the sole treatment approach for potentially serious medical conditions, and should not delay the time it takes to consult with a healthcare professional or receive established therapies. Use cautiously with psychiatric illnesses.
- Relaxation therapy: Relaxation techniques include behavioral therapeutic approaches that differ widely in philosophy, methodology, and practice. Mental health and quality-of-life improvements have been seen in preliminary studies of HIV/AIDS patients. These findings suggest the need for further, well-controlled research.
- Avoid with psychiatric disorders like schizophrenia/psychosis. Jacobson relaxation (flexing specific muscles, holding that position, then relaxing the muscles) should be used cautiously with illnesses like heart disease, high blood pressure, or musculoskeletal injury. Relaxation therapy is not recommended as the sole treatment approach for potentially serious medical conditions, and it should not delay the time to diagnosis or treatment with more proven techniques.
- Selenium: Selenium is a mineral found in soil, water, and some foods. Selenium supplementation has been studied in HIV/AIDS patients, and some reports associate low selenium levels with complications such as cardiomyopathy. It remains unclear if selenium supplementation is beneficial in patients with HIV, particularly during antiretroviral therapy.
- Avoid if allergic or sensitive to products containing selenium. Avoid with history of non-melanoma skin cancer. Selenium is generally regarded as safe for pregnant or breastfeeding women. However, animal research reports that large doses of selenium may lead to birth defects.
- Shiitake: Based on preliminary studies, lentinan from shiitake mushroom may increase CD4 counts and may be effective as an adjunct therapy in HIV. Further well-designed studies are needed to confirm these results. Side effects have been reported and more proven therapies are recommended at this time.
- Avoid if allergic or hypersensitive to shiitake mushrooms. Avoid if pregnant or breastfeeding.
- Sorrel: There is currently not enough evidence on the proposed antiviral effects of sorrel. More research is needed.
- Avoid large doses of sorrel because there have been reports of toxicity and death. This may be because of the oxalate found in sorrel. Many sorrel tinctures contain high levels of alcohol and should be avoided when driving or operating heavy machinery. These sorrel formulations may cause nausea or vomiting when taken with the prescription drugs metronidazole (Flagyl®) or disulfiram (Antabuse®). Avoid if pregnant or breastfeeding.
- Spiritual healing: Distant healing and prayer have been used in patients with HIV/AIDS. There is conflicting evidence in this area and more study is needed.
- Spiritual healing should not be used as the only treatment approach for medical or psychiatric conditions, and should not delay the time it takes to consider more proven therapies.
- Therapeutic touch: There is currently not enough evidence that therapeutic touch may benefit immunity or emotional well-being in HIV/AIDS patients. More research is needed.
- Avoid with fever or inflammation, and on areas of the body with cancer.
- Thymus extract: Thymus extracts for nutritional supplements are usually derived from young calves. Preliminary evidence found no improvement in HIV progression to AIDS or immunostimulation, although some immunological activity was noted in a non-randomized controlled trial. Additional study is needed to better understand the effects of thymus extract for HIV/AIDS.
- Avoid if allergic or hypersensitive to thymus extracts. Use bovine thymus extract supplements cautiously due to potential for exposure to the virus that causes "mad cow disease." Avoid use with an organ transplant or other forms of allografts or xenografts. Avoid if receiving immunosuppressive therapy or hormone therapy. Avoid with thymic tumors, myasthenia gravis (neuromuscular disorder), or untreated hypothyroidism. Avoid if pregnant or breastfeeding. Thymic extract increases human sperm motility and progression.
- Traditional Chinese medicine (TCM): Traditional Chinese medicine (TCM) is a broad term that refers to many different treatments and traditions of healing. They share a common heritage of technique or theory rooted in ancient Chinese philosophy (Taoism) that dates back over 5,000 years. TCM herbs are a popular complementary therapy in HIV/AIDS. However, study results conflict. More studies are needed before the potential benefits of TCM herbs in HIV/AIDS can be established.
- Chinese herbs can be potent and may interact with other herbs, foods, or drugs. Consult a qualified healthcare professional before taking. There have been reports of manufactured or processed Chinese herbal products being tainted with toxins or heavy metal or not containing the listed ingredients. Herbal products should be purchased from reliable sources. Avoid ma huang, which is the active ingredient in ephedra. Avoid ginseng if pregnant or breastfeeding.
- Turmeric: Turmeric is a perennial plant native to India and Indonesia, and it is often used as a spice in cooking. Based on early research, turmeric may help treat various viral infections. Several laboratory studies suggest that curcumin, a component of turmeric, may have activity against HIV/AIDS. However, reliable human studies are lacking in this area.
Well-designed trials are needed.
- Avoid if allergic or hypersensitive to turmeric (curcumin), yellow food colorings, or plants belonging to the Curcuma or Zingiberaceae (ginger) families. Use cautiously with a history of bleeding disorders, immune system deficiencies, liver disease, or gallstones. Use cautiously with blood thinners (e.g. warfarin). Use cautiously if pregnant or breastfeeding.
- Vitamin A: Vitamin A is a fat-soluble vitamin that is derived from two sources:
retinoids and carotenoids. Retinoids are found in animal sources (such as the liver, kidney, eggs, and dairy products). Carotenoids are found in plants like dark or yellow vegetables and carrots. The role of vitamin A in the prevention, transmission, or treatment of HIV infection is controversial and not well established. A clear conclusion cannot be formed based on the available scientific research.
- Avoid if allergic or hypersensitive to vitamin A. Vitamin A toxicity can occur if taken at high dosages. Use cautiously with liver disease or alcoholism. Smokers who consume alcohol and beta-carotene may have an increased risk for lung cancer or heart disease. Vitamin A appears safe in pregnant women if taken at recommended doses. Use cautiously if breastfeeding because the benefits or dangers to nursing infants are not clearly established.
Patients with HIV/AIDS, especially those with low zinc levels, may benefit from zinc supplementation. Some low quality studies cite reduction in infections, enhanced weight gain, and immune system function, including increased CD4 and CD8 cells, with use of zinc. However, other low quality studies conflict with these findings. Further research is needed before a conclusion can be made.
- Zinc is generally considered safe when taken at the recommended dosages. Avoid zinc chloride since studies have not been done on its safety or effectiveness. While zinc appears safe during pregnancy in amounts lower than the established upper intake level, caution should be used since studies cannot rule out the possibility of harm to the fetus.
- Fair negative scientific evidence:
- Ozone therapy: Ozone molecules are composed of three oxygen atoms. Ozone exists high in the earth's atmosphere and absorbs radiation from the sun. Reports of using ozone for medicinal purposes date to the late 19th Century. Laboratory studies have shown the HIV virus to be sensitive to ozone, but high-quality human studies are lacking. A preliminary study measured the safety and effectiveness of ozone-treated blood in the treatment of HIV infection and immune disease. Ozone therapy was not shown to enhance immune activation or diminish the HIV virus.
- Autohemotherapy (a therapy in which blood is withdrawn from the body) infused with ozone, and then replaced into the body), has been associated with transmission of viral hepatitis and with a possible case of dangerously lowered blood cell counts. Insufflation of the ear carries a risk of tympanic membrane ("ear drum") damage, and colon insufflation may increase the risk of bowel rupture. Consult a qualified health professional before undergoing any ozone-related treatment.
- St John's wort:
Anti-viral effects of St. John's wort have been observed in laboratory studies, but were not found in available human study. Multiple reports of significant adverse effects and interactions with drugs used for HIV/AIDS, including protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs), suggest that patients being treated for HIV/AIDS should avoid this herb. Therefore, there is evidence to recommend against using St. John's wort in the treatment of patients with HIV/AIDS.
- Avoid if allergic or hypersensitive to plants in the Hypericaceaefamily. Rare allergic skin reactions like itchy rash have been reported. Avoid with immunosuppressant drugs (such as cyclosporine, tacrolimus, or myophenic acid). Avoid with non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Avoid with organ transplants, suicidal symptoms, or before surgery. Use cautiously with history of thyroid disorders. Use cautiously with drugs that are broken down by the liver, with monoamine oxidase inhibitors (MAOI) or selective serotonin reuptake inhibitors (SSRIS), digoxin, or birth control pills. Use cautiously with diabetes or with history of mania, hypomania, or seasonal affective disorder (SAD). Avoid if pregnant or breastfeeding.
- Ways to prevent acquiring and/or transmitting HIV: Individuals who are either at risk for acquiring HIV or are 13-64 should be tested for HIV annually. This is because this age group is most likely to be sexually active.
- Needles or syringes should be avoided.
- Unprotected sexual contact, including vaginal, anal, or oral sex, should be avoided with an infected person. Unprotected sexual contact with someone with unknown HIV status should also be avoided.
- Behavioral modification may help prevent HIV/AIDS infection. In Uganda, there has been a dramatic decline in HIV prevalence as well as a decline in multi-partner sexual behavior. The decrease in HIV/AIDS infection came after the launch of behavior change programs largely developed by the Ugandan government and local NGOs. The 'ABC' initiative (Abstain, Be faithful, or for those who refuse to do either, use Condoms) resulted in a significant decrease in HIV infections in generalized epidemics. Researchers explained that once the ABC program was launched, rates of 13- to 16-year-olds having sex in one district of Uganda dropped from nearly 60% in 1994 to less than five percent in 2001. Uganda's message for the majority of the population focused on mutual fidelity; the reduction in casual sex, not the elimination of all sex, seems to have led to Uganda's falling HIV rates. Uganda has shown a 70% decline in HIV prevalence since the early 1990s, linked to a 60% reduction in casual sex.
- Gloves should be worn when in contact with blood or other body fluids that could possibly contain blood, such as urine, feces, or vomit.
- Cuts, scrapes, sores, or breaks on the exposed skin of both the caregiver and patient should be covered with bandages.
- Any body area that comes into contact with blood or other body fluids should be thoroughly washed. Surfaces that have been tainted with blood should be disinfected with antibacterial soap.
- Practices that increase the likelihood of blood contact, such as the sharing of razors, toothbrushes, and nail clippers, should be avoided.
- Needles and other sharp instruments should be used only when medically necessary and handled appropriately.
- In 1985, the U.S. Centers for Disease Control and Prevention (CDC) issued a list of routine precautions for all personal-service workers, such as hairdressers, barbers, cosmetologists, and massage therapists, to take. Instruments that penetrate the skin, such as tattoo and acupuncture needles or ear piercing guns, should either be used once and disposed of or thoroughly sterilized. Instruments that are not meant to penetrate the skin, but may come in contact with blood (such as razors), should not be shared unless thoroughly sterilized.
- Antiviral therapy during pregnancy can significantly lower the chance that the virus will be passed to the infant before, during, or after birth. The treatment is most effective if it is started as early as possible during pregnancy. However, there are still health benefits if treatment is begun during labor or shortly after the baby is born.
- Delivering the baby by cesarean section has been shown to reduce the risk of transmission to the newborn. However, this is not the standard preventative care for HIV-infected pregnant women. It should only be considered in certain clinical circumstances (such as for patients who have a very high viral load or for patients who do not adhere to antiretroviral therapy).
- Infected mothers should not breastfeed their newborn(s).
- Preventing drug resistance: The above practices should also be practiced by individuals who are already HIV-positive, especially those receiving highly active antiretroviral therapy (HAART) because they could potentially be transmitting drug-resistant strains of the virus to others. This also applies to sexual partners who are both HIV-positive and receiving HAART because they could potentially transmit different strains of the virus to each other that may be resistant to the partner's HAART. This would make their current therapy ineffective.
- Preventing/delaying the onset of AIDS: HIV patients should receive highly active antiretroviral therapy (HAART), which suppresses the virus and helps restore the body's immune system. Research has shown that HAART dramatically slows the progression of opportunistic infections in HIV/AIDS patients.
- Preventing opportunistic infections: HIV patients may receive medications to help prevent infections from developing. Specific preventative treatment, such as antibiotics, is administered when HIV-infected patients are at risk of developing opportunistic infections or to prevent recurrence of a recent opportunistic infection. Treatment is typically given to patients who have Pneumocystis jiroveci pneumonia, mycobacterium avium complex (MAC), toxoplasmosis, or latent tuberculosis (TB).
- In addition, HIV patients typically receive HAART, which suppresses the virus and helps restore and maintain the immune system. Patients with a healthy or near healthy immune system are less likely to develop opportunistic infections.
- This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).
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- Loutfy MR, Antoniou T, Shen S, et al. Virologic and immunologic impact and durability of enfuvirtide-based antiretroviral therapy in HIV-infected treatment-experienced patients in a clinical setting. HIV Clin Trials. 2007 Jan-Feb;8(1):36-44.
- National Institute of Allergy and Infectious Diseases (NIAD). . Accessed March 29, 2009.
- Natural Standard: The Authority on Integrative Medicine. . Copyright © 2009. Accessed March 29, 2009.
- Rigopoulos D, Gregoriou S, Paparizos V, et al. AIDS in pregnancy, part II: Treatment in the era of highly active antiretroviral therapy and management of obstetric, anesthetic, and pediatric issues. Skinmed. 2007 Mar-Apr;6(2):79-84.
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- General: HIV is transmitted from person to person via bodily fluids including blood, semen, vaginal secretions, and breast milk. Individuals who have other sexually transmitted diseases are more susceptible to the virus. This is because some STDs, such as syphilis, cause breaks in the skin or sores that make it easy for HIV to enter the body.
- HIV is particularly difficult to treat because it reproduces very quickly and has a high mutation rate. When HIV reproduces, different strains (types) of the virus emerge. Mutations (changes in genetic information) occur almost every time a new copy of the virus is produced. Therefore, many types of HIV can be produced in a single person in one day. For this reason, HIV patients receive different combinations of antiretrovirals to suppress the virus.
- HIV primary targets immune cells called CD4 T-cells. The CD4 T-cells are white blood cells that help coordinate the immune system's response to infection and disease. These cells have a molecule called CD4 on their surfaces, which allows the cells to detect foreign substances, including viruses that enter the body. This process then triggers the immune system to destroy the foreign substance. When HIV enters the body, the virus recognizes this protein, binds to the receptors on the CD4 cell wall, and enters the cell. Once inside the cell, HIV replicates and eventually kills the cell.
- Primary, or acute, infection: Patients can transmit the virus to others during all stages of infection. The first stage of HIV, known as the primary or acute infection, is the most infectious stage of the disease, and it typically lasts several weeks. During this phase, the virus replicates rapidly, which leads to an abundance of the virus in the bloodstream and a drastic decline in the number of CD4 T-cells.
The CD8 T-cells, which kill abnormal or infected body cells, are then activated to destroy HIV-infected body cells and antibodies are produced.
- Clinical latency: The next stage, called clinical latency, may last anywhere from two weeks to 20 years. During this phase, HIV is not considered dormant. Instead, it is active in the lymph nodes where large amounts of the virus become trapped. The surrounding tissues, which contain high levels of CD4 T-cells, may also become infected. The virus accumulates in infected cells and in the blood as free virus. Patients generally do not experience symptoms during this stage until the CD4 cell count drops to 600 microliters of blood or lower.
- Symptomatic stage: As the virus continues to weaken the immune system, patients eventually become more susceptible to infections. The next stage is the symptomatic stage, in which the person experiences symptoms associated with a weakened immune system.
The term AIDS (acquired immune deficiency syndrome) refers to the most advanced stage of HIV infection. This stage happens when HIV multiplies rapidly and severely affects the immune system. Individuals have AIDS when they have fewer than 200 CD4 T-cells per microliter of blood. This low CD4 T-cell count makes them extremely vulnerable to potentially fatal opportunistic infections such as pneumonia or tuberculosis.
- Several infections, including Pneumocystis jiroveci pneumonia (formerly called Pneumocystis carinii pneumonia, PCP) and Kaposi's sarcoma (KS), are considered AIDS-defining illnesses. This means that once a patient develops one of these infections, their condition has progressed to AIDS.
- General: Race and ethnicity by themselves do not increase or decrease a person's risk of acquiring HIV infection. However, certain people are more likely to face challenges associated with the risk for HIV infection, such as lack of awareness of HIV status, substance abuse, or socioeconomic issues.
- African Americans:
African Americans accounted for 20,965 (49%) of the 42,514 estimated AIDS cases (not HIV) diagnosed in the United States. The rate of AIDS diagnoses among African American adults and adolescents was 10 times higher than the rate of Caucasians and almost three times higher than the rate of Latinos. In addition, 23 times more African American women were diagnosed with AIDS than Caucasian women. Eight times more African American men were diagnosed with AIDS than Caucasian men, according to the CDC.
In 2004, Latinos accounted for 20% (8,672) of the 42,514 new diagnoses in the United States, according to the CDC. The top causes of infection in most Latino men were infections after HIV exposure through sexual contact with other men, injection drug use, and heterosexual contact. The top causes of infection in Latino women were HIV exposure through heterosexual contact and injection drug use. Latinos were shown to get tested for HIV more often than any other race or ethnicity except African Americans. According to the CDC, in 2004, about 50% of Hispanics between the ages of 15 and 44 were tested, and 18% had been tested during the past year.
After the initial outbreak of HIV, few women were diagnosed with the virus. Today, women account for more than 25% of all new HIV/AIDS diagnoses in the United States. In 2004, an estimated 93,566 women were living with AIDS, making up 23% of the estimated 415,193 people living with AIDS in the United States.
- Youth (13-24 years old): In the United States, it is estimated that 50% of the 40,000 new HIV infections each year occur in people younger than age 25 and 25% of infections occur in people younger than 21. HIV/AIDS ranks as the sixth-leading cause of death among individuals ages 15-24 in the United States, with the number of AIDS cases reported each year in that age group increasing by 417% from 1981 through 1994.
- Injection-drug users: Since the AIDS epidemic began, injection drug use (IDU) with illegal drugs has directly and indirectly (drug use clouds judgment, leading people to engage in high-risk behaviors) accounted for more than one-third of AIDS cases in the United States. In the year 2000, out of the 42,156 new cases of AIDS reported, 11,635 were linked to IDU.
- Injection drug use is more common among racial and ethnic minorities in the United States, which makes them more likely to acquire HIV through IDU. In 2000, IDU accounted for 26% of all AIDS cases among African American adults and 31% among Hispanic adults and adolescents, compared to 19% of all cases among Caucasian adults and adolescents.
- Homosexuals: Men who have sex with men (MSM) accounted for 70% of all estimated HIV infections among male adults and adolescents in 2004 in the United States, according to the CDC. Although the number of HIV diagnoses for MSM decreased during the 1980s and 1990s, the number increased by eight percent from 2003 through 2004. According to the CDC, it is unknown whether this increase is because more people are getting tested for HIV or because more patients are becoming infected with HIV.
- Healthcare workers: Although healthcare workers are exposed to the virus at work, it is unlikely that they will acquire the virus from a patient, especially if they follow universal precautions, which should be taken with all patients.
- For healthcare workers, HIV transmission is most likely to occur through accidental injuries from needles or other sharp medical instruments that may be contaminated with the virus. However, this risk is small. Researchers estimate that about 0.3-1% of healthcare workers exposed to the virus by an accidental needle stick or puncture develop HIV.
- Since December 2001, there have been 57 documented reports of healthcare workers acquiring HIV from a patient. To prevent transmission of HIV to healthcare personnel in the workplace, the U.S. Centers for Disease Control and Prevention (CDC) offers precautionary guidelines.
- Bodily fluids: HIV is transmitted from person to person via bodily fluids because the virus is present in varying concentrations in the blood, semen, vaginal fluid, and breast milk. It can be spread by sexual contact with an infected person, by sharing needles/syringes with someone who is infected, or, less commonly, through transfusions with infected blood. HIV infection through blood transfusion is extremely rare in countries where blood is screened for HIV antibodies.
- Environment: HIV does not survive well in the environment outside of the body. According to studies performed by the U.S. Centers for Disease Control and Prevention (CDC), drying HIV reduces the amount of viral particles by 90-99% within several hours. The virus also cannot reproduce when it is outside of the body. Therefore, it is highly unlikely that the disease can be transmitted through contact with the environment, such as public toilet seats.
- Kissing: Casual contact through closed-mouth or "social" kissing does not put an individual at risk for HIV. However, there is the potential for blood contact with open-mouth kissing. The risk for acquiring the virus from open-mouth kissing is low, and the CDC has only investigated one case in which HIV transmission may have been caused by blood contact during open-mouth kissing. The CDC recommends that individuals avoid open-mouth kissing with an infected person.
There have been medical reports that found that HIV transmission resulted after a human bite. Severe trauma and extensive tissue tearing were reported in each of these cases. However, biting is not a common way of transmitting the disease.
- Saliva, tears, and sweat:
Very low amounts of HIV have been found in the saliva and tears of some AIDS patients. However, a small amount of HIV in body fluid does not necessarily mean that the fluid can transmit the virus. Contact with saliva, tears, or sweat has not been shown to result in transmission of HIV.
According to numerous studies, there is no evidence to suggest that HIV has been transmitted through insects, even in areas such as Africa, that have high numbers of AIDS patients and mosquito populations. HIV can only live for a short time inside an insect and does not reproduce inside insects.
- Effectiveness of condoms:
If a condom is used properly during sexual intercourse, an individual may reduce the risk of acquiring or transmitting STDs, including HIV. Several studies show that using condoms correctly and consistently may reduce the breakage rates of latex condoms to less than two percent.
- There are many types and brands of condoms, but only latex or polyurethane condoms have been shown to effectively prevent HIV transmission when used appropriately.
According to the CDC, natural membrane condoms, such as those made with lambskin, have natural pores that can possibly transmit diseases. Therefore, lambskin condoms are not considered to be effective in preventing HIV transmission.
- Recent evidence has suggested that condom use by high-risk populations increases, rather than decreases the infection rate. According to the latest studies, condom promotion is only effective in lowering the rate of AIDS in concentrated, high-risk groups; condoms have never been shown to reduce HIV infection rates and AIDS deaths in general-population epidemics like those in sub-Saharan Africa. In on study, researchers asserted that of the three interventions scientifically shown to prevent AIDS - abstinence, being faithful, and using condoms - they argue that the use of condoms clearly comes last and should be promoted as a first-line defense only to those in extremely high-risk groups, such as commercial sex workers.
- One prospective study showed that for 'receptive' men during anal sex, it made little or no difference whether their partners used a condom or not. Researchers suggested that condoms are less effective in anal sex than in vaginal sex.
Research and clinical trials
- General: The Pharmaceutical Research and Manufacturers Association of America has a database of new HIV drugs that are in the developmental stage. Researchers are currently testing new protease inhibitors and more potent, less toxic reverse transcriptase inhibitors, as well as drugs that interfere with different steps in the virus' lifecycle.
- Cellular metabolism modulators: Cellular metabolism modulators are undergoing research. These drugs disrupt the cellular processes involved in HIV replication.
- Gene therapy: Gene therapy may be a beneficial treatment in the future. The process involves inserting modified genes (DNA) directly into the body's cells in order to slow or stop HIV from multiplying. Scientists are trying to insert genes that provide the body with instructions on how to produce T-cells that are genetically resistant to the virus.
- Immune modulators: Scientists are also learning how immune modulators, or drugs that alter the immune system, help enhance the immune system's response to HIV in order to potentially make current anti-HIV drugs more effective.
- Maturation inhibitors: Researchers are studying maturation inhibitors, as a potential new class of antiretrovirals. These drugs disrupt the final stage of the HIV life cycle, when new virus particles are released into the blood. Currently, Bevirimat (PA-457) is the only maturation inhibitor undergoing clinical testing. This drug is derived from a Chinese herb called Syzigium claviflorum.
- Portmanteau inhibitors: Portmanteau inhibitors are also being investigated as a possible drug treatment for HIV patients. These inhibitors are a combination of one reverse transcriptase inhibitor (RTI) and one integrase inhibitor.
- Synergistic enhancers: Another group of medications, called synergistic enhancers, may also be used in combination with other antiretroviral drugs to treat HIV. These medications do not act as antiretrovirals when taken alone, but they have been shown to improve the antiretrovirals effects of other drugs, including ritonavir (Norvir®). Very small doses of synergistic enhancers may also be used to reduce the liver metabolism of other antiretroviral drugs. For instance, grapefruit juice is considered a synergistic enhancer that may be beneficial for patients taking antiretrovirals.
- Vaccines: Therapeutic vaccines are also being tested as a way to prevent HIV infection.
- Clinical trials:
- General: HIV/AIDS clinical trials are performed to develop and test more effective and safer ways to diagnose, treat, and prevent HIV/AIDS. A clinical trial is a research study in volunteer human subjects to determine the safety and efficacy of new treatments, screening methods, preventive techniques, or diagnostic methods for a disease. New devices, drugs, procedures, and medical innovations must be thoroughly tested to ensure that they are safe and effective for human patients. Human trials are only conducted after both laboratory and animal studies show promising results.
- Phases of trials: There are four phases of trials. In phase I clinical trials, researchers test a new drug or treatment in a small group of 20-80 patients for the first time. The goal is to evaluate the drug or treatment's safety, determine a safe dosage range, and identify side effects.
- Phase II clinical trials study the effects of a drug or treatment in a larger group of 100-300 patients. During this phase, researchers aim to determine the drug or treatment's efficacy and further assess its safety.
- During phase III trials, researchers study the effect of a drug or treatment in large groups of 1,000-3,000 patients. This type of trial is used to confirm the drug or treatment's effectiveness and monitor side effects. The drug or treatment is also compared to commonly used treatments and researchers collect information that will help ensure that the drug or treatment is used safely.
- Phase IV clinical trials are performed after the drug or treatment has been marketed to the general public. These studies are conducted to collect information on the drug or treatment's long-term effects and side effects in various patient populations.
- Who can participate: All HIV patients can volunteer to participate in clinical trials. However, each clinical trial has unique guidelines for who can participate in the study, called criteria. Patients interested in enrolling in a particular study must meet the criteria. This helps ensure the patient's safety and helps ensure that researchers are able to accurately prove or disprove their hypotheses. Factors that allow a patient to enroll in a clinical trial are called inclusion criteria, and factors that prevent a patient from enrolling are called exclusion criteria. Criteria may include or exclude patients based on factors such as age, medical history, gender, current medications, co-existing illnesses, and overall health.
- Weighing the pros and cons: Participation in clinical trials is completely voluntarily, and the decision should only be made after the patient has carefully considered the potential health benefits and risks. These risks and benefits will be different for each trial and each individual patient. It is important for patients to consult their personal healthcare providers and family members before deciding whether or not to participate in a clinical trial.
- Patients will meet with the researchers before being enrolled in the study. This allows patients to ask any questions and address any concerns about participating. Patients should consider writing down questions ahead of time, asking a friend or family member to join them for support, and/or recording the discussion.
- Participating in a clinical trial allows patients to take an active role in their healthcare. Participants gain access to new treatments that are not available to the public and participants help others by contributing to medical research. However, risks of participating in a trial may include side effects or adverse reactions, the treatment may not be effective, the trial may take up a lot of the patient's time, and participation may require hospital visits or involve complex treatment plans.
- Safety: The federal government has guidelines and safeguards to protect participants in clinical trials. All clinical trials in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and worth the potential benefits. An IRB is an independent committee that consists of physicians, statisticians, community advocates, and other professionals.
- During the trial: The process of each clinical trial is different. The research team generally includes doctors, nurses, and other healthcare professionals. Participants should closely follow the trial's protocol to ensure their safety. Participants are evaluated at the beginning and end of the trial, and their health is monitored continually throughout the trial. Some researchers will stay in touch with participants after the study to perform follow-up tests and/or questionnaires.
- While enrolled in the trial, patients should continue to regularly visit their primary healthcare providers. This helps ensure that the clinical trial protocol is not interfering with the patient's regular medications or treatments.
- Leaving early: Participants can choose to leave a clinical trial at any time. Patients who want to stop participating should let the researcher(s) know why they are leaving the trial.
- Payment: Some clinical trials pay participants to enroll in the study, while others do not. Some trials will reimburse participants for expenses associated with the trial, such as transportation costs, accommodations, meals, or childcare. Potential study participants can discuss whether payment is offered when they meet with the researcher(s). Payment is often not offered if a patient leaves the trial early or does not adhere to protocol.
- AIDSinfo,sponsored by the National Institutes of Health (NIH), provides the latest information about government and industry sponsored HIV/AIDS treatment and prevention clinical trials. AIDSinfo also provides the most current, federally approved guidelines for treating and preventing HIV/AIDS in adults and children. It provides information about AIDS-related illnesses, how to manage occupational exposure to HIV, and how to prevent HIV transmission from mother to child during pregnancy.
- The Elizabeth Glaser Pediatric AIDS Foundation provides treatment to HIV/AIDS patients. The organization promotes the discovery of new treatments for other serious and life-threatening pediatric illnesses.
- The American Foundation for AIDS Research (amfAR) is one of the world's leading nonprofit organizations dedicated to the support of HIV/AIDS research, prevention, treatment education, and the advocacy of AIDS-related public policies.
- The National AIDS hotline is available in English and Spanish, 24 hours a day, seven days a week. The number is: 1-800-CDC-INFO (1-800-232-4636).
Copyright © 2011 Natural Standard (www.naturalstandard.com)
The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.