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HIV Infections clinical trials

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NCT ID: NCT00000879 Completed - HIV Infections Clinical Trials

A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if giving the ALVAC vCP1452 anti-HIV vaccine alone or with another vaccine called AIDSVAX B/B to babies of HIV-positive mothers is safe. The study will also look at how these vaccines affect a baby's immune system. Most HIV-positive children get HIV from their mothers during pregnancy or birth. Treatment with anti-HIV drugs can reduce the baby's risk of getting HIV. Vaccines also may help prevent HIV infection. This study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX B/B vaccine can help the body fight off HIV infection. There is no chance of getting HIV infection from the vaccines. (This study has been changed. In earlier versions, ALVAC vCP205 and AIDSVAX B/E were going to be used.)

NCT ID: NCT00000878 Completed - HIV Infections Clinical Trials

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.

NCT ID: NCT00000877 Completed - HIV Infections Clinical Trials

Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.

NCT ID: NCT00000876 Completed - HIV Infections Clinical Trials

Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children

Start date: n/a
Phase: Phase 1
Study type: Interventional

CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective. HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.

NCT ID: NCT00000874 Completed - HIV Infections Clinical Trials

A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART

Start date: August 1997
Phase: N/A
Study type: Observational

To determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients failing on one of the following regimens: 1. zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV 2. ZDV + 3TC + saquinavir (SQV) 3. ZDV + 3TC + ritonavir (RTV) 4. stavudine (d4T) + 3TC + IDV. [AS PER AMENDMENT 11/26/97: To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor (indinavir [IDV], saquinavir [SQV], ritonavir [RTV], or nelfinavir [NFV]) and two licensed nucleoside reverse transcriptase inhibitors (NRTIs).] A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.

NCT ID: NCT00000873 Completed - HIV Infections Clinical Trials

A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants

Start date: n/a
Phase: N/A
Study type: Interventional

This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants. HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.

NCT ID: NCT00000872 Completed - HIV Infections Clinical Trials

Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection

Start date: n/a
Phase: Phase 2
Study type: Interventional

This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.

NCT ID: NCT00000871 Completed - HIV Infections Clinical Trials

A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers

Start date: n/a
Phase: Phase 2
Study type: Interventional

To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]

NCT ID: NCT00000870 Completed - HIV Infections Clinical Trials

A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone

Start date: n/a
Phase: Phase 2
Study type: Interventional

To compare two different routes of intermittently administered rhIL-2 with a highly active antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following: proportion of patients achieving at least 50-percent increase in CD4 counts above prerandomization baseline values after 1 year of rhIL-2 and the rate of change in CD4 counts. To compare the safety and tolerance of these regimens and their effect on quality of life. To assess the effects of rhIL-2 when combined with HAART on changes in immune cell phenotypes and function and on HIV viral load and the rate of antiviral drug resistance development. The poor responsiveness of late stage HIV-infected patients to rhIL-2 is thought to occur because of low T cell regenerative capacity and high viral burden. If means were available to effectively suppress virus replication, the indigenous immune restorative responses of the host may be further stimulated and enhanced by rhIL-2. The use of protease inhibitors with nucleoside-analogue combination regimens appears to be most effective in controlling virus replication. High-dose intermittent rhIL-2 administered either intravenously or subcutaneously has been shown to be effective in inducing CD4 responses in a number of studies.

NCT ID: NCT00000869 Completed - HIV Infections Clinical Trials

A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery. This study will also test the safety of the drug and see how well it is tolerated by the mother and her baby. Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.