D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Public ClinicalTrials.gov record NCT01565850. 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 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.
Study identification
- NCT ID
- NCT01565850
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- D/C/F/TAF Drug
- DRV Drug
- COBI Drug
- FTC/TDF Drug
- D/C/F/TAF Placebo Drug
- DRV Placebo Drug
- COBI Placebo Drug
- FTC/TDF Placebo 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
- Apr 2012 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Feb 2014 (Actual)
- Last update posted
- Apr 11, 2016
2012 – 2014
United States locations
- U.S. sites
- 43
- U.S. states
- 17
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| AHF Research Center | Beverly Hills | California | 90211 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| Anthony Mills MD, Inc | Los Angeles | California | 90069 | — |
| Orange Coast Medical Group | Newport Beach | California | 92663 | — |
| Alta Bates Summit Medical Center, East Bay AIDS Center | Oakland | California | 94609 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Kasier Permanente Medical Center | San Francisco | California | 94118 | — |
| TPMG--Clinical Trials Unit | San Francisco | California | 94118 | — |
| Apex Research | Denver | Colorado | 80209 | — |
| Denver Infectious Disease Consultants, PLLC | Denver | Colorado | 80220 | — |
| Dupont Circle Physician's 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 | — |
| Gary J. Richmond,M.D.,P.A. | Fort Lauderdale | Florida | 33316 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| IDOCF/ValuhealthMD, LLC | Orlando | Florida | 32806 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University Mercer Medicine | Macon | Georgia | 31201 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Community Research Initiative (CRI) | Boston | Massachusetts | 02215 | — |
| 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 | — |
| North Shore University Hospital / Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Weill Cornell Medical College | New York | New York | 10011 | — |
| ID Consultants, P.A. | Charlotte | North Carolina | 28209 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of South Carolina School of Medicine Division of Infectious Disease | Columbia | South Carolina | 29203 | — |
| Southwest Infectious Disease Clinical Research Inc | Dallas | Texas | 75219 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts, PA | 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 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01565850, 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 Apr 11, 2016 · 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 NCT01565850 live on ClinicalTrials.gov.