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HIV Infections clinical trials

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NCT ID: NCT00718029 Completed - HIV Infections Clinical Trials

Cerebrospinal Fluid (CSF) Raltegravir Substudy

Start date: July 2008
Phase:
Study type: Observational

The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid. The hypotheses are: - Raltegravir concentrations in CSF will be measurable - Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios. - Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.

NCT ID: NCT00717444 Completed - HIV Infections Clinical Trials

Healthy Activities for Prize Incentives

HAPI
Start date: September 2008
Phase: N/A
Study type: Interventional

In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect size estimates of a contingency management (CM) therapy that focuses on improving health, especially as related to increasing low intensity physical activities, such as walking, resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI) intervention will be targeted toward and tested within HIV-positive substance abusers who attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b controlled trial, we will recruit and randomize 70 substance abusing HIV-positive patients to (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus 12-step facilitation therapy. Each intervention will consist of one weekly individual therapy session for 16 weeks. All participants will provide urine and breath specimens twice weekly that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in both conditions will earn the chance to win prizes for submitting drug-negative specimens, and those randomized to the HAPI condition will also earn the chance to win prizes for engaging in healthy activities. Physical activity levels, drug use, psychological symptoms, and subjective and objective indicators of health (body mass index, waist circumference, blood pressure, viral load) will be measured pre-treatment and at months 2 and 4 (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation. Compared to those receiving 12-step facilitation with contingency management for abstinence, we expect that those in the HAPI condition will participate in more physical activities, decrease drug use to a greater extent, evidence reduced depression, and show trends toward improvements in health indices. If effect sizes in at least the small to medium range are noted across all domains, we will consider the therapy appropriate for further evaluation in a Stage 2 therapy development study.

NCT ID: NCT00717067 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

Start date: July 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.

NCT ID: NCT00716040 Active, not recruiting - HIV Infections Clinical Trials

Social-Psychological Intervention to Improve Adherence to HAART

SPIAH-Q
Start date: March 2008
Phase: N/A
Study type: Interventional

All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service. The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.

NCT ID: NCT00713752 Completed - HIV Infections Clinical Trials

Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais

Start date: February 2008
Phase: N/A
Study type: Observational

The purpose of this study is to establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education (no certificate or primary school certificate, less than high school certificate or vocational certificate, high school certificate or higher vocational certificate or diploma, Bachelor degree or higher.

NCT ID: NCT00713531 Completed - HIV Infections Clinical Trials

Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand

Start date: July 2008
Phase: N/A
Study type: Observational

The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include: 1. assess incidence of HIV-1 and volunteer retention 2. describe early viral load and CD4 counts 3. assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials 4. describe volunteer risk behavior

NCT ID: NCT00712088 Completed - HIV Infections Clinical Trials

Project ICARE: Intervening for Community Awareness, Respect, & Empowerment

Start date: July 2008
Phase: N/A
Study type: Interventional

This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).

NCT ID: NCT00711386 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

GSK706769 Repeat Dose Study

Start date: May 16, 2008
Phase: Phase 1
Study type: Interventional

To determine safety, tolerability and Pharmacokinetics of GSK706769

NCT ID: NCT00711230 Completed - HIV Infection Clinical Trials

Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients

GIEU006
Start date: April 2008
Phase: Phase 2
Study type: Interventional

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells. GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

NCT ID: NCT00711009 Completed - Clinical trials for Human Immunodeficiency Virus Infection

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

PROGRESS
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.