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HIV Infections clinical trials

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NCT ID: NCT00307502 Completed - HIV Infections Clinical Trials

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Start date: January 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.

NCT ID: NCT00307164 Completed - HIV Infections Clinical Trials

Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

Start date: September 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy.

NCT ID: NCT00307151 Active, not recruiting - HIV Infections Clinical Trials

Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

P1060
Start date: December 2005
Phase: Phase 2
Study type: Interventional

A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP for prevention of MTCT. >> >> A five year follow up has been added to the study.

NCT ID: NCT00306410 Recruiting - HIV Infections Clinical Trials

The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients

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

The purpose of this study is to determine the effect of normalization of vitamin D levels on bone density, immune and adipocyte function in HIV1-seropositive patients.

NCT ID: NCT00304668 Withdrawn - HIV Infections Clinical Trials

A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.

NCT ID: NCT00304642 Completed - HIV Infections Clinical Trials

A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

Start date: November 2005
Phase: Phase 1
Study type: Interventional

Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.

NCT ID: NCT00303576 Completed - HIV Infections Clinical Trials

A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.

NCT ID: NCT00302822 Completed - HIV Infections Clinical Trials

Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

Start date: April 2006
Phase: Phase 3
Study type: Interventional

HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity. The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment. We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

NCT ID: NCT00302341 Terminated - HIV Infections Clinical Trials

DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately severe Pneumocystis pneumonia (PCP).

NCT ID: NCT00301561 Completed - HIV Infections Clinical Trials

Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)

Start date: May 2006
Phase: Phase 3
Study type: Interventional

Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has developed a follow-up approach based on a simplified monitoring. However, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.