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HIV Infection clinical trials

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NCT ID: NCT00753428 Completed - HIV Infection Clinical Trials

Community-based Evaluation of a Pilot PMTCT Project in Kafue District

Start date: November 2008
Phase:
Study type: Observational

In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate population HIV-free survival among infants born in each target community. The investigators hypothesize that incorporation of routine ART into PMTCT will increase the HIV-free survival of exposed infants to 75%.

NCT ID: NCT00735072 Completed - HIV Infection Clinical Trials

Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure

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

Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications. Blocking the "co-receptor" for HIV might decrease inflammation of the immune system, potentially providing an immune benefit. The goal of the current trial is to determine whether adding maraviroc, a new CCR5 "co-receptor" blocker, decreases inflammation, providing an immune benefit for patients with low CD4 counts despite undetectable viral loads on HIV medications. In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the study medication will be stopped and all subjects will be followed for 12 more weeks. Blood tests measuring the extent of inflammation, low-level viremia, and immune function will be measured throughout the trial and compared between treatment arms.

NCT ID: NCT00724711 Completed - HIV Infection Clinical Trials

Safety and Efficacy Study of Switching From Epzicom to Truvada

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

This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.

NCT ID: NCT00724178 Completed - HIV Infection Clinical Trials

The Effect of Vitamin D and Calcium on Bone in Pediatric HIV

Start date: July 2003
Phase: Phase 2/Phase 3
Study type: Interventional

We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo. The specific aims of this project are to: 1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children. We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo. 2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover. We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo 3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART. We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.

NCT ID: NCT00712530 Completed - HIV Infection Clinical Trials

Single DermaVir Immunization in HIV-1 Infected Patients on HAART

GIHU004
Start date: January 2005
Phase: Phase 1
Study type: Interventional

- DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells. - Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses. - GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).

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: NCT00710593 Completed - HIV Infection Clinical Trials

Impact of an HPV Vaccine in HIV-Infected Young Women

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.

NCT ID: NCT00708162 Completed - HIV Infection Clinical Trials

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

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

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir added to a background regimen (containing a fully-active ritonavir-boosted protease inhibitor [PI/r] and a second agent) in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (elvitegravir arm), or raltegravir plus background regimen (raltegravir arm).

NCT ID: NCT00688311 Completed - HIV Infection Clinical Trials

Pilot Trial of a Synbiotic in HIV+ Patients

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

The goal of this study is to test the hypothesis that daily ingestion of a 'synbiotic' for 4 weeks will improve intestinal function, ease immune system overactivation, and increase blood CD4 count in HIV-infected individuals. A 'Synbiotic' is a mixture of probiotic bacteria and dietary fiber.

NCT ID: NCT00670839 Completed - HIV Infection Clinical Trials

Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

B-BOOST
Start date: May 2008
Phase: Phase 3
Study type: Interventional

HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.