Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

DRUG4 trials

Sponsors

Janssen Sciences Ireland UC, Janssen Pharmaceutica N.V., Belgium, Janssen Research & Development, LLC

Conditions

HealthyImmunodeficiency Virus Type 1, Human

Phase 1

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

CompletedNCT02475135

Janssen Sciences Ireland UCHealthy

Start: 2015-06-01End: 2015-08-14Updated: 2017-10-17

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 3

A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

CompletedNCT02431247

Janssen Sciences Ireland UCImmunodeficiency Virus Type 1, Human

Start: 2015-07-06End: 2020-09-30Updated: 2022-09-28

Related Papers

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

Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies).

2021-06-072 citations

Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1.

2020-12-015 citations

1015. Gastrointestinal (GI) Adverse Events With Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Through Week 96: An AMBER Post Hoc Analysis

Open Forum Infectious Diseases2020-10-01

Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

UNC Libraries2020-08-193 citations

A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

UNC Libraries2020-08-19

Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

AIDS2019-12-1136 citations

Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

AIDS Research and Human Retroviruses2019-09-1313 citations

Bioequivalence of the Once‐Daily Single‐Tablet Regimen of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Compared to Combined Intake of the Separate Agents and the Effect of Food on Bioavailability

Clinical Pharmacology in Drug Development2018-11-098 citations

A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.

2018-07-0158 citations