A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
Public ClinicalTrials.gov record NCT02431247. 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, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.
Study identification
- NCT ID
- NCT02431247
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 725 participants
Conditions and interventions
Conditions
Interventions
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC Drug
- DRV/COBI FDC Drug
- FTC/TDF FDC Drug
- D/C/F/TAF FDC - Matching Placebo Drug
- FTC/TDF FDC Matching Placebo Drug
- DRV/COBI FDC Matching 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
- Jul 6, 2015 (Actual)
- Primary completion
- Mar 2, 2017 (Actual)
- Completion
- Sep 30, 2020 (Actual)
- Last update posted
- Sep 28, 2022
2015 – 2020
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Bakersfield | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | North Hollywood | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Ft. Pierce | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Savannah | Georgia | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Springfield | Massachusetts | — | — |
| Not listed | Berkley | Michigan | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Hillsborough | New Jersey | — | — |
| Not listed | Newark | New Jersey | — | — |
| Not listed | Somers Point | New Jersey | — | — |
| Not listed | Santa Fe | New Mexico | — | — |
| Not listed | Manhasset | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
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 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02431247, 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 Sep 28, 2022 · Synced Oct 19, 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 NCT02431247 live on ClinicalTrials.gov.