CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
D/C/F/TAF FDC +2 moredrug
Likely dose
D/C/F/TAF FDC 800 mgfrom 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/NCT04442737
NCT04442737Phase 4Completed
CompareCT.gov

A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen

Janssen Scientific Affairs, LLC·interventional·Posted Jun 23, 2020·Updated Mar 30, 2025

In Brief

A Phase 4 clinical trial evaluating D/C/F/TAF FDC, TAF/FTC FDC, and 1 other intervention for HIV-1. Completed, enrolled 103 participants across 34 sites.

Detailed Summary

The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.

Study Details

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

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJun 23, 2020
Enrollment StartJul 1, 2020
Primary CompletionAug 7, 2023
Study CompletionAug 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.0 years ago

Interventions

D/C/F/TAF FDCdrug

A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.

TAF/FTC FDCdrug

TAF/FTC ARV regimen will be administered once daily.

INI Based Regimendrug

The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.