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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
Study identification
- NCT ID
- NCT01309243
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 799 participants
Conditions and interventions
Conditions
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 2011 (Type not available)
- Primary completion
- Sep 2012 (Actual)
- Completion
- Feb 2014 (Actual)
- Last update posted
- Feb 25, 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 25, 2015 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01309243 live on ClinicalTrials.gov.