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HIV Infections clinical trials

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NCT ID: NCT03435887 Recruiting - 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 evaluated from 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 Not yet recruiting - HIV Infections Clinical Trials

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

Start date: February 16, 2018
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 Recruiting - HIV Infections Clinical Trials

Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine Isoniazid in HIV+ Patients

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

Single-arm, two-center, Phase I/II clinical trial assessing the pharmacokinetics (PK), safety, and tolerability of once-weekly rifapentine and isoniazid (3HP) for the treatment of latent tuberculosis infection among individuals with HIV infection taking dolutegravir-based (DTG) antiretroviral treatment. The study population will be individuals with HIV taking DTG and 2 nucleoside reverse transcriptase inhibitors for ≥ 4 weeks, who have a suppressed HIV-1 viral load (VL), and are candidates to receive TB preventive therapy. Sample size is 60 participants divided into two main groups Group 1 (1A (n=12) and B (n=18)) and Group 2(n=30). The first 12 participants (Group 1A) will undergo semi-intensive PK sampling and will be key to determining whether an increased dosing of DTG is required in groups 1B and Group 2 due to accelerated DTG clearance due to 3HP induced drug-drug-interactions. Group 1B will receive dolutegravir at the new dose (if applicable) and will also undergo semi-intensive PK sampling. The subsequent 30 (Group 2) will receive DTG at the new dose and will only have sparse PK sampling.

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

Effect of High Dose Vitamin D Supplementation on HIV Latency

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 Not yet recruiting - Clinical trials for Infection, Human Immunodeficiency Virus

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

Start date: April 5, 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

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 Not yet recruiting - HIV Infections Clinical Trials

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

Start date: March 2018
Phase: N/A
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: NCT03413683 Not yet recruiting - HIV Infections Clinical Trials

Frailty in Older HIV-infected Individuals

Start date: February 2018
Phase: N/A
Study type: Observational

Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected individuals in Hong Kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in HIV-infected individuals in Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and without frailty. The following assessment will be done: 1. Physical examination including measuring height, weight, hip and waist circumference. 2. Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests 3. Geriatric syndromes, screening for depression, disability and quality of life. 4. Blood tests during fasting state to measure metabolic parameters. This is a prospective longitudinal observational study that lasts for 10 years.

NCT ID: NCT03409276 Not yet recruiting - 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: February 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.

NCT ID: NCT03408899 Not yet recruiting - HIV Infections Clinical Trials

Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults

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

The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse.