Emtricitabine/Tenofovir Alafenamide

DRUG4 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID), Janssen Pharmaceutica N.V., Belgium, Janssen Research & Development, LLC, Eastern Virginia Medical School

Conditions

Acceptability of Health CareAdherence, MedicationHIV InfectionsHealthy

Phase 1

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

TerminatedNCT04236453

Janssen Pharmaceutica N.V., BelgiumHealthy

Start: 2020-01-23End: 2020-04-10Updated: 2020-07-07

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents

CompletedNCT04661397

Janssen Research & Development, LLCHealthy

Start: 2021-01-05End: 2021-07-02Updated: 2025-02-03

Phase 2

Project Engage: Oral PrEP Acceptability

CompletedNCT05458765

Eastern Virginia Medical SchoolAcceptability of Health Care, Adherence, Medication

Start: 2022-06-21End: 2024-07-25Updated: 2024-07-29

Phase 3

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

CompletedNCT03048422

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2018-01-19End: 2020-10-03Updated: 2022-11-21

Related Papers

Brief Report: Characterizing HIV Drug Resistance in Cases of Vertical Transmission in the VESTED Randomized Antiretroviral Treatment Trial

JAIDS Journal of Acquired Immune Deficiency Syndromes2024-06-252 citations

Dolutegravir- Versus Efavirenz-Based Treatment in Pregnancy: Impact on Red Blood Cell Folate Concentrations in Pregnant Women and Their Infants

The Journal of Infectious Diseases2024-06-131 citations

Bioequivalence of a Pediatric Fixed‐Dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Compared With Coadministration of the Separate Agents in Healthy Adults: An Open‐Label, Randomized, Replicate Crossover Study

Clinical Pharmacology in Drug Development2023-06-192 citations

Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial.

2023-05-0816 citations

Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial.

2021-04-01120 citations