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HIV Infections clinical trials

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NCT ID: NCT00705679 Completed - HIV Infections Clinical Trials

Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

Start date: August 2009
Phase: Phase 2
Study type: Interventional

A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.

NCT ID: NCT00705419 Completed - HIV Infections Clinical Trials

Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)

COVER
Start date: July 2007
Phase: N/A
Study type: Observational

Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.

NCT ID: NCT00704249 Completed - HIV Infections Clinical Trials

VENICE Study Nevirapine Full Dose/Dose Escalation

VENICE
Start date: July 2006
Phase: Phase 4
Study type: Interventional

This study aims to compare the trough plasma concentrations of nevirapine after 7 days of treatment at the full dose from baseline with dose escalation in patients taking efavirenz who switch to nevirapine due to neuropsychiatric adverse reactions.

NCT ID: NCT00703898 Completed - HIV Infections Clinical Trials

Durability of Nevirapine-Based Antiretroviral Regimen

Start date: November 2004
Phase: Phase 4
Study type: Interventional

Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.

NCT ID: NCT00703586 Completed - HIV Infections Clinical Trials

Study of the Antiviral and Immunological Effects of Intensification of Suppressive Antiretroviral Therapy With Maraviroc

Start date: September 2007
Phase: Phase 1
Study type: Interventional

Hypothesis: Intensification of current ARV regimens with maraviroc will result in more complete suppression of viral replication, particularly in the gastrointestinal mucosa with resultant reduction in markers of immune activation and improved GI immune reconstitution.

NCT ID: NCT00703404 Completed - HIV Infections Clinical Trials

Response to Standard HIV Treatment in Bamako, Mali

Start date: June 18, 2008
Phase:
Study type: Observational

This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National HIV Treatment Program. Antiretroviral therapy has become a priority because of its proven effectiveness in decreasing sickness and death from HIV infection. Reliable information on its efficacy is needed. Patients 18 years of age and older who enter the Malian National HIV Treatment Program and have not had prior antiretroviral treatment may be eligible for this study. Primary Objective The primary objective is to measure the virologic treatment response at 24 weeks to the Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune) in patients who are na(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali. Secondary Objectives 1. To assess the association of the 24 week response with the response at one year as measured by suppression of viremia to less than 50 copies/mL 2. To evaluate the baseline clinical and HIV-associated characteristics of a cohort of persons who are enrolled in protocol-mandated monitoring. Participants undergo treatment in the government-sponsored program. Clinical visits are scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12 months. Patients undergo a medical history, including all confirmed and probably diagnoses made since the previous visit and current status, physical examination and blood tests for CD4 and viral load at each visit. Study start date: July 2008

NCT ID: NCT00703248 Completed - HIV Infections Clinical Trials

The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

HOME
Start date: October 2007
Phase: N/A
Study type: Interventional

Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.

NCT ID: NCT00702013 Completed - HIV Infections Clinical Trials

Ontogenesis of the P-Glycoprotein in Human Lymphocytes Influence of HIV and Antiretroviral Therapeutics

Onto-Pgp
Start date: March 2007
Phase: N/A
Study type: Observational

The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the evolution of this transporter's expression and activity on lymphocytes in relation with the human development from newborns to adults. We also aim at studying the influence of HIV and antiretroviral treatments on this transporter, especially anti-protease drugs, within the children population.

NCT ID: NCT00701896 Completed - HIV Infections Clinical Trials

Smoking Cessation Using Motivational Therapy and Varenicline

Start date: October 3, 2008
Phase: N/A
Study type: Interventional

People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

NCT ID: NCT00700284 Completed - HIV Infections Clinical Trials

Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

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

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.