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HIV Infections clinical trials

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NCT ID: NCT02207920 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults

Start date: July 2014
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

NCT ID: NCT02206711 Completed - HIV Infections Clinical Trials

Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

Start date: August 8, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.

NCT ID: NCT02199613 Completed - HIV Infection Clinical Trials

Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir Treatment Simplification Strategy

QuaDar
Start date: October 2014
Phase: Phase 4
Study type: Interventional

The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as a simplification strategy for the treatment of HIV infection in HIV-infected subjects who have had previous antiretroviral treatment experience with multiple-drug regimens. We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will offer a safe and efficacious treatment simplification strategy for HIV positive patients currently receiving multiple-drug regimens to control their HIV infection.

NCT ID: NCT02196831 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Tesamorelin Effects on Liver Fat and Histology in HIV

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.

NCT ID: NCT02196064 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects

Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."

hEPAtic
Start date: May 2014
Phase: N/A
Study type: Observational

To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.

NCT ID: NCT02194179 Completed - HIV Infections Clinical Trials

Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects

Start date: December 2006
Phase: Phase 1
Study type: Interventional

The objective was to establish the pharmacokinetic (PK) profile at steady state of two different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD) under fasted and fed conditions in comparison with the commercially available NVP immediate release (IR) tablet at 200 mg BID (400 mg/day).

NCT ID: NCT02192658 Completed - HIV Clinical Trials

Disability and HIV: Vulnerability of People With Disabilities to HIV Infection in Sub-Saharan Africa

HandiVIH
Start date: November 2014
Phase: N/A
Study type: Observational

According to the recent World Report on Disability, around 15% of the world population lives with a disability and 80% of people with disabilities (PWD) live in developing countries. More and more evidence show that PWD are more likely to be poor, vulnerable to physical and sexual violence, and to have less access to education. Therefore, PWD are likely to have an increased risk for HIV infection, potentially being a key population in regard to this epidemic. The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV is still very limited. As a result, PWD are usually overlooked by National AIDS Control Programmes and few projects specifically targeting them have been developed. Recognizing the need for appropriate and reliable data to help protect the rights of PWD and achieve a better inclusion of disability in National AIDS Control Programmes, the Institute of Research for Development (IRD), the Institut de Formation et Recherche Demographique (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina Faso, in order to define if this vulnerable population is also a Key Population in relation to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and qualitative methods). Quantitative data are collected only in Cameroon. Only the quantitative study is described here.

NCT ID: NCT02191332 Completed - HIV Infections Clinical Trials

Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

Start date: December 1999
Phase: N/A
Study type: Observational

Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

NCT ID: NCT02191319 Completed - HIV Infections Clinical Trials

Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

Start date: January 2002
Phase: N/A
Study type: Observational

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

NCT ID: NCT02191293 Completed - HIV Infections Clinical Trials

Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

Start date: May 2002
Phase: N/A
Study type: Observational

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.