DRV/COBI FDC

DRUG3 trials

Sponsors

Janssen Sciences Ireland UC, Janssen Research & Development, LLC

Conditions

HealthyHuman Immunodeficiency Virus (HIV)Immunodeficiency Virus Type 1, Human

Phase 1

A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children

CompletedNCT05197075

Janssen Research & Development, LLCHuman Immunodeficiency Virus (HIV)

Start: 2022-08-03End: 2022-09-23Updated: 2023-09-14

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants

CompletedNCT05378906

Janssen Research & Development, LLCHealthy

Start: 2022-06-07End: 2022-09-28Updated: 2022-10-26

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

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

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

2018-07-0158 citations