Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
Public ClinicalTrials.gov record NCT01797445. 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 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.
Study identification
- NCT ID
- NCT01797445
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 872 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
- Mar 12, 2013 (Actual)
- Primary completion
- Sep 19, 2014 (Actual)
- Completion
- Oct 3, 2018 (Actual)
- Last update posted
- Mar 2, 2020
2013 – 2018
United States locations
- U.S. sites
- 79
- U.S. states
- 23
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Kaiser Permanente - Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| University of Southern California AIDS Clinical Trials Group | Los Angeles | California | 90033 | — |
| Peter J. Ruane, Inc. | Los Angeles | California | 90036 | — |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | — |
| Alameda County Medical Center | Oakland | California | 94602 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Kaiser Permanente San Francisco | San Francisco | California | 94118 | — |
| Kaiser Permanente | San Leandro | California | 94577 | — |
| Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center | Torrance | California | 90275 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| APEX Research LLC | Denver | Colorado | 80209 | — |
| Greenwich Hospital | Greenwich | Connecticut | 06830 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman-Walker Health | 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 | — |
| Gary J. Richmond,M.D.,P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34952 | — |
| AIDS Healthcare Foundation | Miami | Florida | 33133 | — |
| AIDS Healthcare Foundation | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Idocf/Valuhealthmd | Orlando | Florida | 32836 | — |
| Infectious Diseases Associates of NW FL | Sarasota | Florida | 32504 | — |
| University of South Florida | Tampa | Florida | 33602 | — |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Triple O Research Institute PA | West Palm Beach | Florida | 33401 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | — |
| Emory University | Atlanta | Georgia | 30309 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Infectious Disease Specialist of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University | Macon | Georgia | 31201 | — |
| University of Hawaii - Hawaii Center for AIDS | Honolulu | Hawaii | 96821 | — |
| Rush University Medical Center, Section of Infectious Diseases | Chicago | Illinois | 60305 | — |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02111 | — |
| The Research Institute | West Springfield | Massachusetts | 01105 | — |
| Be Well Medical Center | Berkley | Michigan | 48072-3436 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Central West Clinical Research | St Louis | Missouri | 63108 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Upstate ID Assoc | Albany | New York | 12208 | — |
| North Shore University Hospital - Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Chelsea Village Medical | New York | New York | 10011 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina AIDS Clinical Trials Unit | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center Myer's Park Clinic | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University The Brody School of Medicine | Greenville | North Carolina | 27834 | — |
| Rosedale Infectious Disseases | Huntersville | North Carolina | 28078 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| St. Hope Foundation, Inc. | Bellaire | Texas | 77401 | — |
| Trinity Health & Wellness Center / AIDS Arms, Inc. | Dallas | Texas | 75215 | — |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | — |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts, PA | 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 | — |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01797445, 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 Mar 2, 2020 · 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 NCT01797445 live on ClinicalTrials.gov.