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Completed Phase 3 Interventional Results available

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

ClinicalTrials.gov ID: NCT01309243

Public ClinicalTrials.gov record NCT01309243. 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 Jun 26, 2026, 12:00 PM 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 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Study identification

NCT ID
NCT01309243
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
799 participants

Conditions and interventions

Interventions

  • FTC/RPV/TDF Drug
  • EFV/FTC/TDF Drug

Drug

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
Jan 31, 2011
Primary completion
Aug 31, 2012
Completion
Jan 31, 2014
Last update posted
Feb 24, 2015

2011 – 2014

United States locations

U.S. sites
83
U.S. states
25
U.S. cities
62
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294
Spectrum Medical Group Phoenix Arizona 85012
AHF Research Center Beverly Hills California 90211
Kaiser Permanente Medical Center Hayward California 94545
Living Hope Education and Research Consultants Long Beach California 90813
Kaiser Permanente Medical Center Los Angeles California 90027
Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center Los Angeles California 90028
Lightsource Medical Los Angeles California 90036
Cedars-Sinai Medical Center Los Angeles California 90048
Oasis Clinic Los Angeles California 90059
Anthony Mills MD Inc Los Angeles California 90069
Orange Coast Medical Group Newport Beach California 92663
East Bay AIDS Center Oakland California 94609
Stanford University Palo Alto California 94304
University of California, Davis Sacramento California 95817
Kaiser Permanente Medical Group Sacramento California 95825
La Playa Medical Group and Clinical Research San Diego California 92103
Metropolis Medical/Dr.Fritz San Francisco California 94114
Kaiser Permanente Medical Center, San Francisco San Francisco California 94118
Apex Research LLC Denver Colorado 80209
Dupont Circle Physician's 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
Medical Faculty Associates Washington D.C. District of Columbia 20037
Broward General Medical Center Fort Lauderdale Florida 33311
Gary J. Richmond, M.D., P.A. Fort Lauderdale Florida 33316
Midway Immunology and Research Center Ft. Pierce Florida 34982
The Kinder Medical Group Miami Florida 33133
Wohlfeiler, Piperato and Associates, LLC Miami Beach Florida 33139
Orlando Immunology Center Orlando Florida 32803
Valuhealthmd,Llc / Idocf Orlando Florida 32806
Infectious Disease Associates of NW FL Pensacola Florida 32504
AHF Health Positive - Tampa Bay Safety Harbor Florida 34695
St. Joseph's Hospital d/b/a Comprehensive Research Institute Tampa Florida 33614
Emory University Atlanta Georgia 30306
AIDS Research Consortium of Atlanta Atlanta Georgia 30308
Atlanta ID Group Atlanta Georgia 30309
Infectious Disease Specialists of America Decatur Georgia 30033
Mercer University School of Medicine Macon Georgia 31201
Clint Spencer Clinic Honolulu Hawaii 96813
Northwestern University Chicago Illinois 60611
Howard Brown Health Center Chicago Illinois 60613
Northstar Medical Center Chicago Illinois 60657
Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station Lutherville Maryland 21093
Community Research Initiative of New England Boston Massachusetts 02111
Claudia T Martorell, MD., LLC dba The Research Institute Springfield Massachusetts 01105
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, Inc. St Louis Missouri 63108
Southampton Healthcare St Louis Missouri 63139
Saint Michael's Medical Center Newark New Jersey 07102
South Jersey Infectious Disease Somers Point New Jersey 08244
Southwest Care Center Sante Fe New Mexico 87505
Upstate Infectious Disease Associates Albany New York 12208
New York Hospital Queens Flushing New York 11355
North Shore University Hospital--Division of Infectious Diseases Manhasset New York 11030
Greiger Clinic Mount Vernon New York 10550
Beth Israel Medical Center New York New York 10003
Ricky K. Hsu, Md, Pc New York New York 10011
Montefiore Medical Center The Bronx New York 10467
Clinical and Translational Research Center - UNC Hospitals Chapel Hill North Carolina 27599
Carolinas Medical Center Charlotte North Carolina 28207
Duke University Medical Center Durham North Carolina 27710
The Brody School of Medicine at 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 Care Center Akron Ohio 44203
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104
Philadelphia FIGHT Philadelphia Pennsylvania 19107
University of South Carolina Columbia South Carolina 29223
Central Texas Clinical Research Austin Texas 78705
Trinity Health and Wellness Center Dallas Texas 75208
Southwest Infectious Disease Associates, Inc. Dallas Texas 75219
Tarrant County Infectious Disease Associates Fort Worth Texas 76104
Garcia Family Health Group Harlingen Texas 78550
Therapeutic Concepts, P.A. Houston Texas 77004
Gordon E. Crofoot MD PA Houston Texas 77098
DCOL Center for Clinical Research Longview Texas 75605
CARE-ID Annandale Virginia 22003
Peter Shalit, M.D. 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 68 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01309243, 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 Feb 24, 2015 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01309243 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →