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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

NCT02431247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 725

Last updated 2022-09-28

Study results available
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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.

Conditions

  • Immunodeficiency Virus Type 1, Human

Interventions

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.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-06
Primary Completion
2017-03-02
Completion
2020-09-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431247 on ClinicalTrials.gov