Active clinical trials for "HIV Infections"

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.

This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a cytokine with immunomodulatory properties. Currently 73 patients have been approved to receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and viral parameters will be closely monitored during this time for evidence of toxicity and preliminary evidence of efficacy.

This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD. The anticipated accrual will be approximately 15 patients and the study will take one year to complete. Patients will receive Proleukin® (Registered Trademark) subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin® (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone. If tolerated, each patient will receive 3 cycles of therapy and, following completion of three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy.

The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients. IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.

The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients. IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).

To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts <= 200/mm3 who are enrolled in protocol CPCRA 042.] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.

To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.

The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.