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HIV Infections clinical trials

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NCT ID: NCT00559403 Completed - HIV Infections Clinical Trials

Effect of HIV/STD Risk Reduction Program on South African Adolescents

Start date: October 2004
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

NCT ID: NCT00557245 Completed - HIV Infections Clinical Trials

Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

Partners PrEP
Start date: May 2008
Phase: Phase 3
Study type: Interventional

Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.

NCT ID: NCT00554567 Completed - HIV Infections Clinical Trials

Utilization of HIV Clinical Services in Rural India

Start date: January 2007
Phase: Phase 3
Study type: Interventional

This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.

NCT ID: NCT00554398 Completed - HIV Infections Clinical Trials

Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression

Start date: November 2007
Phase: Phase 3
Study type: Interventional

An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir.

NCT ID: NCT00553930 Completed - HIV Infections Clinical Trials

Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients

SAEI_IFN_1
Start date: November 2007
Phase: Phase 4
Study type: Interventional

Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients. Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions. Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point wall be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.

NCT ID: NCT00552240 Completed - HIV Infections Clinical Trials

Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Start date: September 2007
Phase: Phase 4
Study type: Interventional

The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).

NCT ID: NCT00551720 Completed - HIV Infections Clinical Trials

Motivation and Patch Treatment for HIV-positive Smokers

Positive PATHS
Start date: January 1999
Phase: Phase 3
Study type: Interventional

The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine patch, with the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the SC control treatment. All study participants were offered use of the nicotine patch.

NCT ID: NCT00551655 Completed - HIV Infections Clinical Trials

Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients

Start date: May 2007
Phase: Phase 4
Study type: Observational

Tenofovir (TDF)-containing regimens may be associated with decreasing renal function in HIV-infected patients concurrently treated with boosted PI's and/or have co-morbid conditions including diabetes mellitus, hypertension, anemia, hepatitis B, and hepatitis C.

NCT ID: NCT00551330 Completed - HIV Infections Clinical Trials

Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED)

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to investigate in subjects with detectable dual/mixed CCR5/CXCR4-tropic HIV whether vicriviroc when added to other appropriate HIV drugs can decrease the level of HIV (viral load) in the blood and that it is well tolerated. This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects infected with dual/mixed CCR5/CXCR4-tropic virus and who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or PI) or at least 6 months experience with at least 2 of the following: one NRTI, one NNRTI, or one PI (excluding low-dose ritonavir) and failure on their current stable regimen. The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening, history of prior antiretroviral drug use by the patient, and drug toxicity. Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. An interim analysis will be performed when all subjects have completed 24 weeks of treatment. Subjects who complete 48 weeks of treatment, or who discontinue early but are deemed eligible upon rescreening, will be offered participation in the open-label segment of the study, and will receive vicriviroc 30 mg once daily, if appropriate, until commercially available or until the sponsor terminates the clinical development of vicriviroc.

NCT ID: NCT00551018 Completed - HIV Infections Clinical Trials

Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected treatment-naïve subjects.