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HIV Infections clinical trials

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NCT ID: NCT01068873 Terminated - HIV Infections Clinical Trials

Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)

KALMAR
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.

NCT ID: NCT01049932 Terminated - HIV Infections Clinical Trials

Pre-Exposure Prophylaxis Using TMC278LA

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection. The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.

NCT ID: NCT01049204 Terminated - HIV Infections Clinical Trials

Impact of Maraviroc on the Immune Function in HIV-1 Infected Subjects Receiving Immunisation With Novel Antigens

Start date: July 2009
Phase: Phase 4
Study type: Interventional

Impact of Maraviroc, a ART CCR5 inhibitor, on the intensification of immune function in HIV-1 infected subjects receiving immunisation with novel antigens The purpose of the study is to investigate the impact of adding Maraviroc (an anti-HIV agent) to a participant's normal HIV medication, on immune function. As part of the study participants will also receive three different vaccinations and a skin test. The study will also look at whether Maraviroc influences the body's response to these. The vaccines are given to stimulate the body's immune system, so we can therefore evaluate the impact that Maraviroc has on this. The duration of the study will be just over 24 weeks plus a screening period up to 4 weeks prior to the start of the study.

NCT ID: NCT01040039 Terminated - HIV Infections Clinical Trials

Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV

Start date: November 2009
Phase: N/A
Study type: Observational

This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy.

NCT ID: NCT01031849 Terminated - HIV Infections Clinical Trials

Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir

BIOKAL
Start date: February 2010
Phase: Phase 4
Study type: Interventional

The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)

NCT ID: NCT01026727 Terminated - HIV Infections Clinical Trials

A Study to Assess the Long-term Efficacy (24 Weeks) of MPC-4326 in Combination With a 2-3 Drug OBR Relative to the Efficacy of a 3-4 Drug ARV Regimen in Treatment Experienced HIV-1 Infected Subjects Who Are Failing Current Antiretroviral Therapy

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

This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a 3-4 antiretroviral (ARV) regimen in treatment experienced, HIV-1 infected subjects.

NCT ID: NCT01014481 Terminated - HIV Infections Clinical Trials

Appropriate Timing of HAART in Co-infected HIV/TB Patients

TIME
Start date: October 2009
Phase: Phase 4
Study type: Interventional

To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

NCT ID: NCT00998582 Terminated - HIV Infections Clinical Trials

Artery Elasticity After Switch From Epzicom to Truvada

Start date: October 2009
Phase: Phase 4
Study type: Interventional

Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease risk, among patients taking abacavir as part of their HIV medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2) continue to take abacavir.

NCT ID: NCT00986999 Terminated - HIV Infections Clinical Trials

Effect of Rosuvastatin on Endothelial Function

Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins. The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).

NCT ID: NCT00981773 Terminated - HIV Infections Clinical Trials

The St. Marys and The Mater Switch Study

SMASH
Start date: September 2009
Phase: Phase 4
Study type: Interventional

The aim of the study is to determine whether switching from an antiretroviral regimen containing abacavir and/or didanosine to one containing maraviroc will lead to a reduction in platelet reactivity and inflammatory markers at weeks 12 and 24 thereby conferring a reduction in cardiac risk. In addition the study will assess the efficacy of a maraviroc containing regimen in combination with a boosted protease inhibitor in terms of tolerability and achieving long term viral suppression as assessed at week 48. The investigators hypothesize that there will be a rapid reduction in platelet reactivity on switching to maraviroc and that a boosted protease inhibitor in combination with maraviroc will provide a safe and efficacious antiretroviral regimen enabling a reduction in cardiac risk whilst maintaining virological suppression.