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HIV Infections clinical trials

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NCT ID: NCT03441984 Completed - HIV Infections Clinical Trials

To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers

Start date: February 26, 2018
Phase: Phase 1
Study type: Interventional

This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.

NCT ID: NCT03435887 Completed - HIV Infections Clinical Trials

Piloting At-birth Point of Care HIV Testing Strategies in Kenya

Start date: December 2, 2016
Phase: N/A
Study type: Interventional

Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.

NCT ID: NCT03435783 Completed - HIV Infections Clinical Trials

Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

Start date: October 13, 2017
Phase: N/A
Study type: Interventional

The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.

NCT ID: NCT03435146 Completed - HIV Infections Clinical Trials

Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)

IMPAACT4TB
Start date: January 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Single-arm, single-center, Phase I/II clinical trial, in four groups. Individuals with HIV infection taking Efavirenz (EFV) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable (Groups 1 and 2) or detectable (Group 3 and 4) HIV viral load and an indication for TPT, will be switched to DTG with tenofovir/emtricitabine (Groups 1 and 2) or lamivudine/tenofovir (Groups 3 and 4). Group 1 and 2 will receive weekly HP for 12 total doses starting 8 weeks after initiating DTG. Individuals who are on an existing DTG-based plus two NRTI ART regimen for at least eight weeks (and have not received efavirenz or nevirapine for at least two months) who have an undetectable HIV viral load may also participate. Individuals with HIV infection who are ART treatment naïve at any HIV viral load level and have an indication for TPT will start DTG and be enrolled to receive standard IPT (Group 3) or HP (Group 4) initiated at the same time as DTG. Group 3 and 4 will be enrolled after follow up of Group 1 and 2 has been completed.

NCT ID: NCT03426592 Completed - Clinical trials for Human Immunodeficiency Virus

Effect of High Dose Vitamin D Supplementation on HIV Latency

VIVA
Start date: January 29, 2018
Phase: Phase 2
Study type: Interventional

HIV persists despite antiretroviral therapy (ART) and is associated with chronic inflammation. This inflammation is thought to prevent an effective immune response against the virus and is mediated at least in part by gut epithelial permeability and microbial translocation. HIV accumulates preferentially within Th17 cells with time on ART; these memory CD4+ T cells are highly susceptible to HIV infection and are concentrated within the gut. Vitamin D promotes gut epithelial integrity in animal models and exerts anti-inflammatory effects on the human immune system including down-modulation of Th17 cell frequency. This study will evaluate whether high dose vitamin D is able to reduce immune activation and Th17 cell frequency, to improve gut barrier integrity and the gut microbiome and reduce HIV persistence in participants on long-term suppressive ART.

NCT ID: NCT03422172 Completed - HIV Infections Clinical Trials

A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men

Start date: April 10, 2018
Phase: Phase 1
Study type: Interventional

The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection. CAB possesses attributes that allow formulation and delivery as a LA parenteral product. CAB is being developed as both oral and long acting (LA) injectable formulations. This study is designed to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during injection phase of the study. Approximately 60 subjects will be screened, of which, approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection phase of the study. The maximum study duration will be approximately 89 weeks including oral phase, injection phase and follow-up phase.

NCT ID: NCT03416881 Completed - HIV Infections Clinical Trials

Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study

POPVIH65
Start date: January 1, 2016
Phase: N/A
Study type: Observational

Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpool base.

NCT ID: NCT03414411 Completed - HIV Infections Clinical Trials

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort: The 4F Study

Start date: February 20, 2018
Phase:
Study type: Observational

The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol and/or drug use to: 1) test the associations between alcohol (and illicit drugs and polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and whether frailty mediates these associations; and 2) test the associations between alcohol (and illicit drugs and polypharmacy) and utilization (emergency department use and hospitalization for falls and fractures), and whether frailty mediates them. To achieve the stated aims the investigators will expand (to 400) and continue to follow an existing prospective cohort (The Boston ARCH Cohort) of adults with HIV infection and a high prevalence of exposure to alcohol, other drugs, and polypharmacy. The Boston ARCH Cohort is a longitudinal cohort (1-3.5 years of follow-up) of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use.

NCT ID: NCT03414372 Completed - Hiv Clinical Trials

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

NCT ID: NCT03409276 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults

Start date: March 16, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.