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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01095796

Public ClinicalTrials.gov record NCT01095796. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01095796
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
707 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2010 (Type not available)
Primary completion
Aug 2011 (Actual)
Completion
Sep 2014 (Actual)
Last update posted
Nov 11, 2015

2010 – 2014

United States locations

U.S. sites
97
U.S. states
27
U.S. cities
66
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Spectrum Medical Group Phoenix Arizona 85012 —
Health for Life Clinic PLLC Little Rock Arkansas 72207 —
AHF Research Center Beverly Hills California 90211 —
Kaiser Permanente Hospital Hayward California 94545 —
Living Hope Clinical Foundation Long Beach California 90813 —
Kaiser Permanente Los Angeles California 90027 —
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic Los Angeles California 90028 —
UCLA Center for Clinical Aids Research and Education Los Angeles California 90035 —
Peter J. Ruane, MD, Inc. Los Angeles California 90036 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Anthony Mills, MD, Inc. Los Angeles California 90069 —
Orange Coast Medical Group Newport Beach California 92663 —
Alameda County Medical Center Oakland California 94602 —
East Bay AIDS Center Oakland California 94609 —
Stanford University Palo Alto California 94303 —
Kaiser Permanente Medical Group Sacramento California 95825 —
La Playa Medical Group and Clinical Research San Diego California 92103 —
San Francisco General Hospital, University of California, San Francisco San Francisco California 94110 —
Metropolis Medical San Francisco California 94115 —
Kaiser Permanente Medical Center, Clinical Trials Unit San Francisco California 94118 —
Apex Research, LLC Denver Colorado 80209 —
Yale University HIV Clinical Trials Program New Haven Connecticut 06033 —
The Stamford Hospital Stamford Connecticut 06902 —
Dupont Circle Physicians Group Washington D.C. District of Columbia 20009 —
Whitman-Walker Clinic Washington D.C. District of Columbia 20009 —
Capital Medical Associates, PC Washington D.C. District of Columbia 20036 —
George Washington University Medical Faculty Associates Washington D.C. District of Columbia 20037 —
Therafirst Medical Center Fort Lauderdale Florida 33308 —
Broward Health/Comprehensive Care Center Fort Lauderdale Florida 33311 —
Gary J. Richmond, MD, PA Fort Lauderdale Florida 33316 —
Midway Immunology and Research Center Ft. Pierce Florida 34982 —
The Kinder Medical Group Miami Florida 33133 —
University of Miami School of Medicine Miami Florida 33136 —
Wohlfeiler, Piperato and Associates, LLC Miami Beach Florida 33139 —
Orlando Immunology Center Orlando Florida 32803 —
Idocf/ Valuhealthmd, Llc Orlando Florida 32806 —
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department Tampa Florida 33602 —
Infectious Disease Research Institute Inc. Tampa Florida 33614 —
St. Joseph's Comprehensive Research Institute Tampa Florida 33615 —
Treasure Coast Infectious Disease Consultants Vero Beach Florida 32960 —
AIDS Research Consortium of Atlanta Atlanta Georgia 30308 —
Emory University Atlanta Georgia 30308 —
Atlanta ID Group, PC Atlanta Georgia 30309 —
Infectious Disease Specialists of Atlanta Decatur Georgia 30033 —
Mercer University School of Medicine Macon Georgia 31210 —
Leahi Hospital Honolulu Hawaii 96816 —
Ruth M. Rothstein CORE Center Chicago Illinois 60612 —
Howard Brown Health Center Chicago Illinois 60613 —
Johns Hopkins University School of Medicine Baltimore Maryland 21205 —
Brigham & Women's Hospital Boston Massachusetts 02115 —
Community Research Initiative Boston Massachusetts 02215 —
The Research Institute Springfield Massachusetts 01107 —
Baystate Infectious Diseases Clinical Research Springfield Massachusetts 01199 —
Be Well Medical Center Berkley Michigan 48072 —
Henry Ford Health System Detroit Michigan 48202 —
Hennepin County Medical Center Minneapolis Minnesota 55415 —
Central West Clinical Research St Louis Missouri 63108 —
Southampton Healthcare St Louis Missouri 63139 —
ID Care Hillsborough New Jersey 08844 —
Saint Michaels Medical Center Newark New Jersey 07102 —
South Jersey Infectious Disease Somers Point New Jersey 08244 —
Garden State Infectious Diseases Associates, PA Voorhees Township New Jersey 08043 —
SouthWest CARE Center Sante Fe New Mexico 87505 —
Upstate ID Association Albany New York 12208 —
SUNY Downstate Medical Center Brooklyn New York 11203 —
New York Hospital Queens Flushing New York 11355 —
North Shore University Hospital Manhasset New York 11030 —
Greiger Clinic Mount Vernon New York 10550 —
Beth Israel Medical Center New York New York 10003 —
Chelsea Village Medical, PC New York New York 10011 —
Ricky K. Hsu, MD, PC New York New York 10011 —
The Aaron Diamond AIDS Research Center New York New York 10016 —
Montefiore Medical Center - AIDS Center The Bronx New York 10467 —
Jacobi Medical Center The Bronx New York 31210 —
Clinical and Translational Research Center Chapel Hill North Carolina 27599 —
Carolinas Medical Center-Myers Park Charlotte North Carolina 28207 —
Duke University Medical Center Durham North Carolina 27710 —
East Carolina University Greenville North Carolina 27834 —
Rosedale Infectious Diseases Huntersville North Carolina 28078 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Summa Health System Akron Ohio 44304 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Philadelphia FIGHT Philadelphia Pennsylvania 19107 —
University of South Carolina Columbia South Carolina 29203 —
Southwest Infectious Disease Clinical Research, Inc. Dallas Texas 75204 —
Peabody Health Center Dallas Texas 75215 —
Tarrant County Infectious Disease Associates Fort Worth Texas 76104 —
Valley AIDS Council Harlingen Texas 78550 —
Therapeutic Concepts Houston Texas 77004 —
Gordon E. Crofoot MD PA Houston Texas 77098 —
Research Access Network Houston Texas 77098 —
DCOL Center for Clinical Research Longview Texas 75605 —
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID) Annandale Virginia 22003 —
Peter Shalit, MD Seattle Washington 98104 —
Rockwood Pulmonary and Critical Care Spokane Washington 99204 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01095796, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 11, 2015 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01095796 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →