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HIV Infections clinical trials

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NCT ID: NCT00122538 Completed - HIV Infections Clinical Trials

Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to try a known antiretroviral combination in HIV- infected children with only one intake a day, in order to simplify the prescription and improve adherence to treatment. This is what is called a phase II clinical trial, only recruiting and following a small number of children (50) during one year to evaluate the quantity of drug in the blood just before it is taken and one to three hours after it is taken. The other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

NCT ID: NCT00122486 Completed - HIV Infections Clinical Trials

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.

NCT ID: NCT00121979 Completed - HIV Infections Clinical Trials

Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects

Start date: September 2004
Phase: Phase 2
Study type: Interventional

Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine, Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®). The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when used together with other HIV drugs in people who have previously been treated with 3TC (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at approximately 11 study sites in the US and Latin America.

NCT ID: NCT00121758 Completed - HIV Infections Clinical Trials

AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers

Start date: September 2004
Phase: Phase 2
Study type: Interventional

This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.

NCT ID: NCT00121121 Completed - HIV Infections Clinical Trials

Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers

Start date: July 2004
Phase: Phase 1
Study type: Interventional

Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.

NCT ID: NCT00120757 Completed - HIV Infections Clinical Trials

Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

Start date: October 2004
Phase: Phase 3
Study type: Interventional

Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

NCT ID: NCT00120510 Completed - HIV Infections Clinical Trials

Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti

Start date: July 2007
Phase: N/A
Study type: Interventional

Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.

NCT ID: NCT00120471 Completed - HIV Infections Clinical Trials

Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

Start date: November 2006
Phase: Phase 1
Study type: Interventional

To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.

NCT ID: NCT00120393 Completed - HIV Infections Clinical Trials

Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

Start date: January 2004
Phase: Phase 3
Study type: Interventional

Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).

NCT ID: NCT00120367 Completed - HIV Infections Clinical Trials

Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)

Start date: April 2005
Phase: Phase 2
Study type: Interventional

Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain, provoked by the JC virus. It usually occurs in subjects with impaired immune system as during HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But it was shown in the setting of HIV-related PML, that combination antiretroviral therapy allows a restoration of the immune system and then might stop the progression of PML. The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML. This research program will involve 30 patients in several centres in France. All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs. The total duration of follow-up for a patient will be of 1 year.