Overview

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

Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Sciences Ireland UC
Treatments:
Cobicistat
Darunavir
Emtricitabine
Emtricitabine tenofovir alafenamide
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir
Criteria
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