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HIV Infection clinical trials

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NCT ID: NCT01614626 Completed - HIV Infection Clinical Trials

Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

Start date: November 2012
Phase:
Study type: Observational

The purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.

NCT ID: NCT01612858 Active, not recruiting - HIV Infection Clinical Trials

Metabolic Abnormalities in HIV-infected Persons

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.

NCT ID: NCT01612455 Completed - HIV Infection Clinical Trials

Linking Infectious and Narcology Care in Russia

LINC
Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.

NCT ID: NCT01606722 Completed - HIV-infection Clinical Trials

Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy

MonDar
Start date: January 2010
Phase: N/A
Study type: Observational

To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.

NCT ID: NCT01601626 Terminated - Tuberculosis Clinical Trials

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Start date: July 13, 2013
Phase: Phase 2
Study type: Interventional

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART). This study compared three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a PI together with rifabutin-based anti-TB treatment.

NCT ID: NCT01576731 Completed - HIV Infection Clinical Trials

Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)

RAL-PEP
Start date: July 2012
Phase: Phase 4
Study type: Interventional

As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP). Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe. Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up. A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.

NCT ID: NCT01571466 Completed - HIV Infection Clinical Trials

A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART

2009-016578-34
Start date: September 2011
Phase: Phase 1
Study type: Interventional

30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.

NCT ID: NCT01557998 Completed - HIV Infection Clinical Trials

Testing and Linkage to Care for Injecting Drug Users in Kenya

Start date: May 2012
Phase: N/A
Study type: Interventional

Testing and Linkage to Care for Injecting Drug Users in Kenya: Interventions for people who inject drugs (PWID) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they contribute a growing proportion of incident HIV infections. This study will leverage a historic decision in Kenya to launch needle exchange program (NSP) and related services for this most-at-risk population (MARP). The investigators will use this NSP/MARP platform to seek out PWID, deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers, and evaluate community viral load impact using a stepped wedge cluster-randomized design. Lessons learned will have important applicability throughout sub-Saharan African. HCV Among PWID in Kenya: A Supplement to the TLC-IDU study: The prevalence of HCV in Kenya, where an increasing number of people who inject drugs (PWID) live and are becoming HIV- as well as HCV-infected, has not been defined. We will establish HCV prevalence among PWID in Nairobi, Western, and Coastal region by adding HCV rapid and confirmatory tests in our parent PWID study (TLC-IDU Kenya); deliver appropriate counseling and treatment options to those eligible; collect HCV treatment adherence data; and disseminate study findings. These data will provide novel and relevant information about HCV and HIV co-infection in Kenya among PWID that will be immediately applicable in terms of public health impact to national and regional HCV testing, counseling, and clinical management policy.

NCT ID: NCT01555723 Withdrawn - HIV Infection Clinical Trials

Observational Study of Antiretroviral (ARV) Response in a Cohort of African Children Using Viral Load Monitoring

RELATES
Start date: n/a
Phase: N/A
Study type: Observational

Background: Treatment of HIV-1 infected Ugandan children with antiretroviral therapy (ART) is increasing but few prospective long-term studies evaluating the treatment process have been reported. In this study we sought to determine prospectively how consistent monitoring of HIV-1 RNA levels impacts the ART treatment process. Methods: One hundred and eight children initiating ART were enrolled into this study. These children had comprehensive laboratory monitoring including HIV-1 RNA level determination and genotype analysis (where appropriate), CD4 % plus absolute counts, and safety laboratory measurements performed prior to starting therapy and at regular intervals after receiving ART. Kaplan-Meier statistics were used to examine predictors of survival and virologic failure. Viral genotype analysis was performed on samples obtained from children having virologic failure to determent the emergence of mutations.

NCT ID: NCT01543035 Completed - HIV Infection Clinical Trials

Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs

ETRALL
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL) cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in HIV-infected individuals, and has been associated with HIV infection itself and antiretroviral therapy (ART). These abnormalities are well-established markers of cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk of CVD associated with ART exposure over and above that conveyed by traditional cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual clinical strategy remains to add a statin treatment. Recent studies suggested ART switch can represent an interesting alternative to statins to reduce lipid plasma levels. The purpose of this study is to evaluate the frequency with which the replacement of LPV/r (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate the necessity to administer statins. A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed. At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined. Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will be measured at baseline, at drug switch and at the end of the study Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for study drug will be done at week-4 and week-12, Returned study medication will be counted and the amount notified on the Case Report Form (CRF).