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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Immunodeficiency Virus Type 1, Human

Treatments: Drug: D/C/F/TAF FDC - Matching Placebo; Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC; Drug: FTC/TDF FDC; Drug: DRV/COBI FDC Matching Placebo; Drug: DRV/COBI FDC; Drug: FTC/TDF FDC Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02431247

TMC114FD2HTX3001 (Other Identifier)

2015-000754-38 (EudraCT Number)

CR107277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 725 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time
• Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to >=1,000 copies per milliliter (copies/mL)
• Cluster of Differentiation 4+ (CD4+) cell count >50 cells/microliter (cells/mcL)
• Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC
• Screening eGFRcreatinine >=70 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Exclusion criteria

• Subject has been diagnosed with a new acquired immunodeficiency syndrome (AIDS)-defining condition within the 30 days prior to screening
• Subject has proven or suspected acute hepatitis within 30 days prior to screening
• Subject is hepatitis C or hepatitis B positive
• Subject has a history of cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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725 participants in 2 patient groups

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide

Experimental group

Description:

Subject will receive a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination \[FDC\]) once daily along with DRV/COBI FDC-matching and FTC/TDF FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding visit, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96.

Treatment:

Drug: FTC/TDF FDC Matching Placebo

Drug: DRV/COBI FDC Matching Placebo

Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

DRV/COBI fixed dose combination (FDC) and FTC/TDF FDC

Active Comparator group

Description:

Subject will receive DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96.

Treatment:

Drug: D/C/F/TAF FDC - Matching Placebo

Drug: FTC/TDF FDC

Drug: DRV/COBI FDC