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D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

NCT01565850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2016-04-11

Study results available
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Summary

This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Conditions

  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Interventions

DRUG

D/C/F/TAF

DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily

DRUG

DRV

DRV 800 mg (2 × 400 mg tablets) administered orally once daily

DRUG

COBI

COBI 150 mg tablet administered orally once daily

DRUG

FTC/TDF

FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily

DRUG

D/C/F/TAF Placebo

D/C/F/TAF placebo tablet administered orally once daily

DRUG

DRV Placebo

DRV placebo tablet administered orally once daily

DRUG

COBI Placebo

COBI placebo tablet administered orally once daily

DRUG

FTC/TDF Placebo

FTC/TDF placebo tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Moupali Das, MD, MPH · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-01-31
Completion
2014-02-28

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

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 NCT01565850 on ClinicalTrials.gov