Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
Public ClinicalTrials.gov record NCT01968551. 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 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive 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) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
Study identification
- NCT ID
- NCT01968551
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 158 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
- Sep 3, 2013 (Actual)
- Primary completion
- Jul 21, 2015 (Actual)
- Completion
- Jul 9, 2016 (Actual)
- Last update posted
- Nov 16, 2018
2013 – 2016
United States locations
- U.S. sites
- 56
- U.S. states
- 22
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians, Ltd. | Phoenix | Arizona | 85015 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Kaiser Permanente | Hayward | California | 94545 | — |
| Long Beach Education and Research Consultants | Long Beach | California | 90813 | — |
| Peter J Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| Kaiser San Francisco Division of Research | San Francisco | California | 94118 | — |
| Dupont Circle Physician's Group | Washington D.C. | District of Columbia | 20009 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Gary J.Richmond, MD, P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Valuhealthmd/Idocf | Orlando | Florida | 32806 | — |
| Infectious Diseases Associates of NW FL | Pensacola | Florida | 32504 | — |
| Hillsborough County Health Department | Tampa | Florida | 33602 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| AIDS Research and Treatment Center of the Treasure Coast | Vero Beach | Florida | 32960 | — |
| Triple O Research Institute PA | West Palm Beach | Florida | 33401 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30312 | — |
| Mercer University, Mercer Medicine | Macon | Georgia | 31201 | — |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Johns Hopkins University | Lutherville | Maryland | 21093 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Harvard Medical School | Boston | Massachusetts | 02215 | — |
| Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts | 01199 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55404 | — |
| The Kansas City Free Health Clinic/ KC Care Clinic | Kansas City | Missouri | 64111 | — |
| Central West Clinical Research | St Louis | Missouri | 63108 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| New York Hospital Queens | Flushing | New York | 11355 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Weill Medical College | New York | New York | 10011 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Carolinas Medical Center--Myer's Park | Charlotte | North Carolina | 28207 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| East Carolina University The Brody School of Medicine, Infectious Diseases | Greenville | North Carolina | 27858 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System CARE Center | Akron | Ohio | 44304 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| North Texas infectious Diseases Consultants, PA | Dallas | Texas | 75246 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Gordon E. Crofoot MD PA | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75606 | — |
| University of Utah | Salt Lake City | Utah | 84102 | — |
| Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID) | Annandale | Virginia | 220003 | — |
| 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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01968551, 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 16, 2018 · Synced Oct 24, 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 NCT01968551 live on ClinicalTrials.gov.