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HIV Infections clinical trials

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NCT ID: NCT01479868 Completed - Clinical trials for Hepatitis C Virus Genotype-1

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

NCT ID: NCT01479296 Completed - HIV Infections Clinical Trials

Evaluating the Immune Response to a rAd5 HIV Vaccine Administered in Three Different Ways in Healthy, HIV-Uninfected Adults

Start date: December 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the immune response to the Vaccine Research Center (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways, in healthy, HIV-uninfected adults.

NCT ID: NCT01475890 Completed - HIV-infection/Aids Clinical Trials

Vitamin D Supplementation in HIV

Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in children, adolescents and young adults with Human Immunodeficiency Virus and acquired immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332.

NCT ID: NCT01475838 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

NCT ID: NCT01473472 Completed - HIV Infection Clinical Trials

On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

IPERGAY
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.

NCT ID: NCT01471574 Completed - Clinical trials for Hepatitis C, Genotype 1

Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

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

The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

NCT ID: NCT01467531 Completed - Clinical trials for Infections, Human Immunodeficiency Virus and Hepatitis

A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.

NCT ID: NCT01467518 Completed - Clinical trials for Infections, Human Immunodeficiency Virus and Hepatitis

Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.

Start date: December 2011
Phase: Phase 1
Study type: Interventional

Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection. As HIV-infected subjects may also be receiving methadone for opioid dependence, an evaluation of the potential interaction between DTG and methadone is warranted. The primary objective of this study is to determine whether concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a secondary endpoint, the PK of DTG will be compared to historical data. This study will be open-label with subjects receiving DTG and stable doses of methadone. The study will be conducted at one center in Canada in adult male and female subjects.

NCT ID: NCT01467349 Completed - HIV Infections Clinical Trials

Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

Real-Life
Start date: December 2011
Phase: N/A
Study type: Observational

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting. Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first. The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.

NCT ID: NCT01461096 Completed - HIV Infections Clinical Trials

Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Men who have sex with men (MSM) have an increased risk of developing anal human papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal HPV infection in HIV-infected MSM and HIV-infected women.