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HIV Infections clinical trials

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NCT ID: NCT03702998 Not yet recruiting - HIV Infections Clinical Trials

Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population

Start date: November 2018
Phase:
Study type: Observational

This is a retrospective study, all HIV-infected individuals followed up at the three designated HIV clinics in Hong Kong with and without HBV and/or HCV co-infection will be included in the analysis. The incidence and mortality of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined.

NCT ID: NCT03699241 Not yet recruiting - HIV Infections Clinical Trials

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

Start date: October 15, 2018
Phase: Phase 1
Study type: Interventional

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

NCT ID: NCT03695393 Not yet recruiting - HIV Infections Clinical Trials

Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs

SCRIPT
Start date: January 2019
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) among 100 HIV-positive people with injection drug use, which aims to test the feasibility of the SCRIPT intervention and evaluate its effectiveness on the reduction of internalized stigma, as well as entry into substance use treatment or initiation of antiretroviral therapy.

NCT ID: NCT03685500 Not yet recruiting - HIV Infections Clinical Trials

A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c)

DETOX
Start date: October 15, 2018
Phase: Phase 4
Study type: Interventional

A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)

NCT ID: NCT03682939 Not yet recruiting - HIV Infections Clinical Trials

Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population

ProPositive
Start date: September 2018
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.

NCT ID: NCT03682848 Not yet recruiting - HIV Infections Clinical Trials

Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents

Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens. Thus, there is great interest from subjects and clinicians in unique regimens that might avoid such toxicities by minimizing the number of antiretrovirals without sacrificing long-term antiviral efficacy. DTG plus 3TC is a novel, well-tolerated first-line regimen for HIV-infected treatment- naive subjects, limiting the risk of many common adverse reactions associated with other antiretroviral drugs. Thus, this study is designed to evaluate the efficacy and safety of DTG/3TC as a FDC, in ART-naive HIV-1-infected adolescents, who weigh at least 40 kilograms. The study will consists of Screening Phase (up to 28 days prior to the first dose of drug) followed by Treatment Phase (up to 48 weeks). Subjects who successfully complete 48 weeks of therapy and who continue to receive benefit from DTG/3TC FDC may enter a 96-week study Extension Phase. All subjects will receive the FDC of DTG/3TC (50/300 milligrams) for once daily. Approximately 30 subjects will be enrolled in the study.

NCT ID: NCT03678181 Not yet recruiting - HIV Infections Clinical Trials

Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The overall goal of this 3-arm randomized trial is to test whether a network-driven online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes among young Black and/or Latino men who have sex with men and transgender women.

NCT ID: NCT03677960 Not yet recruiting - HIV Infection Clinical Trials

Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Start date: October 8, 2018
Phase: Phase 1
Study type: Interventional

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection

NCT ID: NCT03675815 Not yet recruiting - HIV Infections Clinical Trials

Body Composition Sub-study of the D2EFT Trial

Start date: November 15, 2018
Phase: Phase 4
Study type: Interventional

This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.

NCT ID: NCT03674983 Not yet recruiting - HIV Infections Clinical Trials

PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico

Start date: September 17, 2018
Phase: N/A
Study type: Interventional

The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.