MedTrace Logo

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

NCT01095796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2015-11-11

Study results available
· View outcomes & findings →

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 efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

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

Atripla

Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime

DRUG

Stribild Placebo

Placebo to match Stribild STR administered orally once daily

DRUG

Atripla Placebo

Placebo to match Atripla tablet administered orally once daily prior to bedtime

Sponsors & Collaborators

Principal Investigators

  • Martin Rhee, 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
2010-03-31
Primary Completion
2011-08-31
Completion
2014-09-30

Countries

  • United States
  • Puerto Rico

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 NCT01095796 on ClinicalTrials.gov