NCT02431247

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

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

Detailed description

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participant know what treatment the participant is receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard \[control\] treatment or procedure) study. The study consists of 5 periods: a Screening period, Double-blind treatment period, Single-arm treatment period, Extension period and a Follow-up period. Participants will receive either darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed dose combination (D/C/F/TAF FDC) or DRV/COBI FDC along with FTC/TDF FDC. Primarily percentage of participants with human immunodeficiency virus (HIV) -1 Ribonucleic acid (RNA) less than (\<) 50 copies per milliliter (copies/ml) defined by snapshot analysis will be evaluated. Participants' safety will be monitored throughout the study.

Conditions

• Immunodeficiency Virus Type 1, Human

Interventions

Type	Name	Description
DRUG	Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC	A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.
DRUG	DRV/COBI FDC	A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.
DRUG	FTC/TDF FDC	A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.
DRUG	D/C/F/TAF FDC - Matching Placebo	Matching placebo of D/C/F/TAF FDC will be administered once daily.
DRUG	FTC/TDF FDC Matching Placebo	Matching placebo of FTC/TDF FDC will be administered once daily.
DRUG	DRV/COBI FDC Matching Placebo	Matching placebo of DRV/COBI FDC will be administered once daily.

Timeline

• Start date: 2015-07-06
• Primary completion: 2017-03-02
• Completion: 2020-09-30
• First posted: 2015-04-30
• Last updated: 2022-09-28
• Results posted: 2018-09-14

Locations

80 sites across 10 countries: United States, Belgium, Canada, France, Germany, Poland, Puerto Rico, Russia, Spain, United Kingdom