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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

NCT01108510 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2016-05-23

Study results available
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Summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

COBI

Cobicistat (COBI) 150 mg tablet administered orally once daily

DRUG

RTV

Ritonavir (RTV) 100 mg tablet administered orally once daily

DRUG

ATV

Atazanavir (ATV) 300 mg capsule administered orally once daily

DRUG

FTC/TDF

Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

DRUG

COBI placebo

Placebo to match COBI administered orally once daily

DRUG

RTV placebo

Placebo to match RTV administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Huyen Cao, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2015-04-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Dominican Republic
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Spain
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT01108510 on ClinicalTrials.gov