CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 109 enrolled
Drug / intervention
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDCdrug
Likely dose
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDCfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03227861
NCT03227861Phase 3Completed
CompareCT.gov

A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care

Janssen Scientific Affairs, LLC·interventional·Posted Jul 24, 2017·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC for HIV-1. Completed, enrolled 109 participants across 16 sites.

Detailed Summary

The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartJul 31, 2017
Primary CompletionJan 3, 2019
Study CompletionSep 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.9 years ago

Interventions

DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDCdrug

Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.