A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

Phase 4 Completed 103 enrolled Janssen Scientific Affairs, LLC

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-07-01
Primary completion: 2023-08-07
Completion: 2023-08-30

Outcome

Missed primary endpoint

paper No significant difference in weight change was observed at week 24 PMID 39230668 ↗

Publications

Anderson D, Ramgopal M, Hagins DP, Lee J, Simonson RB, Hsu TH, Xu P, Ahmad N, Short WR. DEFINE: A Prospective, Randomized, Phase 4 Trial to Assess a Protease Inhibitor-Based Regimen Switch Strategy to Manage Integrase Inhibitor-Related Weight Gain. Clin Infect Dis. 2025 Mar 17;80(3):602-612. doi: 10.1093/cid/ciae449.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobicistat	Small molecule	150 mg	—
Subject	Darunavir	Small molecule	800 mg	—
Comparator	emtricitabine	Other / unclassified	200 mg	—
Comparator	tenofovir alafenamide	Small molecule	10 mg	—
Comparator	Bictegravir	Small molecule	—	—
Comparator	Dolutegravir	Other / unclassified	—	—
Comparator	Raltegravir	Other / unclassified	—	—
Comparator	elvitegravir	Small molecule	—	—
Comparator	emtricitabine	Other / unclassified	—	—
Comparator	tenofovir alafenamide	Small molecule	—	—

Indications

No indication recorded.