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Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT01106586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 708

Last updated 2015-11-11

Study results available
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Summary

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

Stribild

Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

DRUG

ATV

Atazanavir 300 mg capsule administered orally once daily

DRUG

Ritonavir

Ritonavir (RTV; /r) 100 mg tablet administered orally once daily

DRUG

FTC/TDF

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

DRUG

Stribild Placebo

Placebo to match Stribild administered orally once daily

DRUG

ATV Placebo

Placebo to match ATV administered orally once daily

DRUG

RTV Placebo

Placebo to match RTV administered orally once daily

DRUG

FTC/TDF Placebo

Placebo to match FTC/TDF administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Marshall Fordyce, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-09-30
Completion
2014-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Sweden
  • 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 NCT01106586 on ClinicalTrials.gov