View clinical trials related to HIV Infections.
Filter by:The purpose of this study is to see how the body's immune system changes after replacing and adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that make disease-fighting cells). Substudy A5155s will be performed to see how many latently infected cells are in the blood before and after replacing and adding anti-HIV drugs. ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients. Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed. However, most of these patients still have problems with their immune systems. The reason for these problems is unknown. This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood.
The purpose of this study is to determine the effect of massage therapy on depression, quality of life and plasma cortisol levels in subjects with advanced HIV disease.
The purpose of this study is to determine the immunomodulatory and antiviral effects of the glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive to highly active antiretroviral treatment (HAART).
Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well-being for patients with advanced AIDS, and evaluate its effects on dimensions of well-being and quality of life.
This study will evaluate a new treatment strategy called therapeutic drug monitoring (TDM) in HIV-infected children and adolescents. TDM involves analyzing the virus, giving drugs the virus is most sensitive to, monitoring drug blood levels to make sure there is enough drug to work against the virus, and changing the drug dose if it is too low. HIV-infected children between 0 and 21 years of age who may benefit from treatment with a protease inhibitor and who are not benefiting from their current antiretroviral drug treatment regimen may be enrolled in this 48-week study. Patients who are not currently receiving antiretroviral treatment, including patients who have never received antiretroviral treatment, may be enrolled in the study. Participants will have blood drawn to learn what anti-HIV drugs the patient's virus is resistant to-that is, what drugs are no longer effective against the virus. This is determined by analyzing the virus's genotype (detailed genetic structure) and phenotype (response to exposure to anti-viral drugs). Based on these test results and the patient's prior medication history, a drug regimen tailored to the individual patient will be prescribed. It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse transcriptase inhibitor such as nevirapine or efavirenz, and a protease inhibitor such as amprenavir, nelfinavir, saquinavir, ritonavir, or Kaletra (a combination of lopinavir and ritonavir). After the patients begin treatment, the amount of the protease inhibitor in the blood will be measured. If not enough of the drug is found in the blood, the dose of the drug will be increased and the amount of the drug in the blood will be checked again. In this study, the dose may be increased up to three times. Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of the medicines and evaluate the response of the virus. Treatment will then continue on an outpatient basis. Drug levels will be measured periodically throughout the study. The viral load will also be measured and additional tests to determine whether the resistance pattern of the patients' virus has changed. In addition, patients will undergo the following tests and procedures at various times throughout the study, more frequently for the first few months and then less often: - Blood tests to measure cell counts and viral load - Routine laboratory tests to measure kidney, liver, bone marrow, and other organ functioning - Eye and neuropsychologic examinations - Echocardiogram (heart ultrasound) - Electrocardiogram (EKG - heart rhythm test) - Chest X-ray - Computed tomography (CT) scan of the head - Skin tests To make sure the medicines work, they must be taken as directed. In addition, since higher than usual doses of some of the anti-HIV drugs may be given, it will be important to know whether the patients are taking all of the medicine that has been prescribed. This study will therefore also measure patients' adherence to their medication regimen in two ways: 1) some medicines will be packaged in a bottle with an electronic medicine bottle cap that will record when the bottle is opened, and 2) patients and their parents will be interviewed by phone or in person at various times during the study about adherence and may be asked to fill out forms that record the number of doses taken. This will allow the doctor and patient to work together to make sure the medicines are being taken properly. Patients and parents will also be interviewed periodically about their understanding of HIV disease, about social supports that are available, and about the child's emotional adjustment.
This study will evaluate how controlling HIV infection with HAART (highly active antiretroviral therapy) affects the response to hepatitis C treatment with peginterferon alpha-2b and ribavirin in HIV-infected patients with chronic hepatitis C. HIV worsens liver disease caused by hepatitis C. Since treatment of HIV infection with HAART improves immune function, it may be beneficial to start HAART before treating HCV. HIV-infected patients 18 years of age and older with chronic hepatitis C infection may be eligible for this study. Patients must have an HCV viral load greater than 2000 copies/mL and a CD4 count that is either more than 500 cells/mm3, or more than 350 cells/mm3 with an HIV viral load no greater than 40,000 particles/mL. Candidates will be screened for current or previous diseases, conditions or treatments that may exclude them from this study. Screening includes a medical history and physical examination, eye examination, blood and urine tests, chest X-ray, electrocardiogram (EKG), liver ultrasound, and, possibly, a liver biopsy, if a recent one is not available. The liver biopsy is optional and is done to determine the severity of liver disease. Patients will be sedated for this test. The skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. Patients remain in the hospital overnight for monitoring. Women of childbearing age will have a pregnancy test. Patients enrolled in the study will be randomly assigned to one of the following treatment groups: 1) pegylated interferon and ribavirin for 48 weeks (control group); or 2) HAART for 6 months, followed by 48 weeks of pegylated interferon and ribavirin. HAART group - Patients taking HAART will be followed in the clinic every 2 weeks for the first month and then monthly for the next 5 months. After 6 months of HAART they will begin taking pegylated interferon and ribavirin and will follow the dosing and follow-up schedule outlined below for patients in the control group. Control group - Patients will have weekly injections under the skin of peginterferon alpha-2b and ribavirin pills daily by mouth. Clinic visits will be scheduled as follows: - Days 1, 3, 7, and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. HCV medications will be injected on days 7 and 21. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56, and 64 - Blood and urine tests will be done to determine the side effects of pegylated interferon and ribavirin treatment and its effect on the HCV infection. Eye examinations will be done every 3 months. - Week 48 or end of treatment - Treatment with pegylated interferon and ribavirin will stop after 48 weeks. At this time (or earlier for those who do not complete the 48 weeks of treatment), patients will return to the clinic for a routine visit, blood tests (including a test for hepatitis B) and abdominal ultrasound. Patients may also be hospitalized for 2 days for a repeat optional liver biopsy. - Week 72 and extended follow-up visits - At week 72, patients will return for blood tests and a routine clinic visit. HCV viral load will be measured. Follow-up visits every 3 months for an additional year will include a blood test to measure HCV viral load and a complete physical examination.
Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS. Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled. Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study: - Medical history, including history of sexual activity and drug use - Physical examination - Pregnancy test for women of childbearing age - Blood and urine tests to evaluate possible medical problems such as liver and kidney function; to evaluate immune function; and to test for HIV, hepatitis and syphilis Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.
The purpose of this study is to see if an investigational vaccine can make antibodies (proteins found in blood) in humans that will influence the course of an AIDS-like disease in monkeys. Hopefully, the results of this study can be applied to humans. AIDS, which is caused by infection with HIV, is associated with many deaths and occurrences of disease. Although recent advances have been made in anti-HIV therapy for AIDS, there is no cure for HIV infection or AIDS, and drug therapy is too expensive for most infected populations. Some organizations are trying to make safe and effective vaccines that may prevent HIV infection and AIDS worldwide. Certain vaccines can generate specific antibodies in humans, but they do not inhibit HIV infection in laboratory tests. It is possible, however, that these antibodies may make HIV disease less severe following infection. For this reason, monkeys will be used to evaluate the role of specific human antibodies.
The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART.