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HIV Infections clinical trials

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NCT ID: NCT02474901 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults

QLAIV
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine if there is a difference in shedding (primary objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and HIV-negative children and young adults who are receiving the quadrivalent live-attenuated influenza vaccine (QLAIV).

NCT ID: NCT02473367 Completed - HIV Infection Clinical Trials

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

Start date: June 23, 2015
Phase: Phase 1
Study type: Interventional

In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.

NCT ID: NCT02471430 Completed - HIV Infection Clinical Trials

Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy

ACTIVATE
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a prospective, open-label, randomized, three-arm, dose-escalation exploratory pilot clinical trial involving HIV-1 infected participants treated with suppressive combination antiretroviral combination therapy (cART). The study will test whether combined treatment with the histone deacetylase inhibitor panobinostat and the immunomodulatory cytokine Interferon-alpha2a can reduce the residual reservoir of HIV-1 infected cells that persist during treatment with currently available antiretroviral drugs.

NCT ID: NCT02471326 Completed - HIV Clinical Trials

VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

Start date: July 13, 2015
Phase: Phase 1
Study type: Interventional

Background: - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART. Objective: - To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART. Eligibility: - Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks. Design: - Participants will be screened with: - Physical exam - Medical history - Heart tests - Blood and urine tests. - Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1. - Visit 1: Repeat screening procedures. - Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm. - They will get the first study drug dose through a thin tube in an arm vein for about 1 hour. - For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis. - Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.

NCT ID: NCT02467335 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

Start date: January 29, 2015
Phase: Phase 1
Study type: Interventional

A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.

NCT ID: NCT02464423 Completed - Clinical trials for Human Immunodeficiency Virus

Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model

Start date: January 2013
Phase: N/A
Study type: Interventional

Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic, accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health priority, but Rwandan youth are more than twice as likely to be on second line therapy than adults, and with a median population age of 18.7 years old, adherence is essential for Rwanda's future. Resources to provide youth-centered medical and psychosocial care are limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the long-term consequences of genocide, depression, and gender-based violence, as well as logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e., TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling need for innovative programs to increase ART adherence among HIV+ youth. If effective, the study will build Rwanda's capacity to provide much needed services; and, involvement by the Rwanda Biomedical Center will ensure wide dissemination.

NCT ID: NCT02463227 Completed - HIV Infections Clinical Trials

Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption

Start date: August 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines. The study examined whether VRC01 controlled or delayed the return of HIV viremia when the participants' HIV medicines were briefly stopped during the study.

NCT ID: NCT02462772 Withdrawn - Clinical trials for Human Immunodeficiency Virus

Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa

CAPRISA014
Start date: October 2015
Phase: Phase 2
Study type: Interventional

The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA) injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in KwaZulu-Natal, South Africa.

NCT ID: NCT02461576 Completed - Clinical trials for Human Immunodeficiency Virus

Clinical Evaluation of the Xpert® HIV-1 VL

Start date: July 2015
Phase: N/A
Study type: Observational

Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.

NCT ID: NCT02460900 Completed - HIV Clinical Trials

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIV/AIDS who smoke to quit. The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit smoking.