Active clinical trials for "HIV Infections"

The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective combination drug therapy for HIV patients who have failed a nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy.

The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160 MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive patients. HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses. One way to strengthen these responses may be to have a safe and effective vaccine, which will boost immune responses that are specific to HIV.

The purpose of this study is to determine the effectiveness of recombinant human growth hormone (r-hGH) on growth in HIV-infected children. Studies have shown that HIV-infected children do not grow at a normal rate and are shorter than HIV-uninfected children who are the same age. Growth hormone has been used for many years to treat children with growth hormone deficiency and has been safe and effective in helping them to grow normally. The growth hormone to be used in this study, r-hGH, is an investigational hormone (not yet approved by the Food and Drug Administration [FDA]) made in the laboratory. It has helped HIV-positive adults gain weight and improve their physical performance. This study has been changed to include a needle-free device for drug delivery which will improve patient comfort and acceptability. Patients will no longer receive growth hormone through traditional needles but through a needle-free device.

This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows HIV disease progression in patients with low CD4+ T cell counts compared with patients taking ART alone. CD4+ T cells are a subset of lymphocytes-white blood cells that are part of the body's immune system. IL-2 is a protein that is naturally produced by lymphocytes. Given in intermittent cycles, IL-2 can raise CD4+ T cell counts in some HIV-infected patients taking antiretroviral drugs. This study will examine whether the increase in CD4+ T cells lowers the risk of AIDS-related illnesses and death. HIV-infected patients 18 years of age and older with a viral load under 10,000 copies per milliliter and a CD4+ T cell count between 50 and 299 cells per cubic millimeter who are taking antiretroviral therapy and who have not previously received IL-2 therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Participation in the study will be from 4.5 to 6 years, depending on what point in the duration of the study the individual patient is enrolled. Patients will be randomly assigned to receive IL-2 plus ART or ART alone. All participants will be advised individually about the best ART regimen for them. Patients in the IL-2 treatment group will be taught how to self-inject IL-2 under the skin (similar to insulin injections). They will inject IL-2 twice a day for 5 days every 8 weeks for the first year (until week 49 of the study). From week 49 on they may receive 5-day cycles of IL-2 every 4 months when needed to maintain CD4+ T cell count elevations. An extra cycle may be given 2 months after the week 49 follow-up visit (see follow-up schedule below), depending on their CD4+ T cell count. Patients whose cell counts have not increased after 12 to 16 months of IL-2 treatment will discuss with the doctor the possibility of stopping IL-2. Those who do stop IL-2 treatment will be asked to remain in the study for follow-up evaluations. All patients will be followed in the clinic every 2 months for the first year of the study (weeks 1, 9, 17, 25, 33, 41 and 49) and every 4 months during years 2-6 for a brief history and physical exam, urine and blood tests, return of diary cards (record of drug side effects) and medication review. During the visits from the second year on, patients will also be asked about their ability to do certain ordinary tasks, such as taking care of themselves; ...

The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.

This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of the viral infection towards AIDS. However, this treatment is not problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to because of the many pills and capsules that must be taken daily. When patients stop taking HAART, their viral levels climb again. This study will see if T-20 can prolong the time it takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may provide insight into possible new HAART-sparing treatments. HIV-infected patients 18 years of age and older who have received HAART for at least 1 month may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG). Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients will then be evaluated once a month until their viral level is less than 50. The final clinic visit will be one month after this time. In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and possibly again when they restart HAART and at the end of the study. For this procedure, whole blood is collected through a needle placed in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. The white cells are used to study T cell function and levels and to detect hidden virus.

The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.

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.

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.

Ritonavir (RTV) is a protease inhibitor (PI) commonly used to increase drug levels of other PIs in HIV drug treatment. The purpose of this study is to compare a combination of drugs which includes RTV and 2 protease inhibitors (PIs) with 2 combinations that include RTV and another PI. This study also will compare the effectiveness, safety, tolerability, and drug levels in the blood of these anti-HIV drug combinations.