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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 Sep 3, 2026, 1:05 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
Feb 28, 2010
Primary completion
Jul 31, 2011
Completion
Aug 31, 2014
Last update posted
Nov 10, 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 10, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01095796 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →