Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
Public ClinicalTrials.gov record NCT02121795. 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, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
Study identification
- NCT ID
- NCT02121795
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 668 participants
Conditions and interventions
Conditions
Interventions
- FTC/TDF Drug
- F/TAF Drug
- Allowed third antiretroviral agent Drug
- FTC/TDF Placebo Drug
- F/TAF 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
- May 6, 2014 (Actual)
- Primary completion
- Aug 12, 2015 (Actual)
- Completion
- Mar 1, 2019 (Actual)
- Last update posted
- Mar 12, 2020
2014 – 2019
United States locations
- U.S. sites
- 57
- U.S. states
- 19
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Kaiser Permanente | Hayward | California | 94545 | — |
| Tarrant County ID Associates | Los Angeles | California | 90036 | — |
| Southern California Men's Medical Group | Los Angeles | California | 90069 | — |
| Highland Hospital - Alameda Health System (formerly Alameda County medical Center) | Oakland | California | 94602 | — |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Kaiser Permanente Medical Group San Francisco | San Francisco | California | 94118 | — |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Kaiser Permanente Colorado | Denver | Colorado | 80205 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Apex Research LLC | Denver | Colorado | 80209 | — |
| 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 | Washington D.C. | District of Columbia | 20036 | — |
| Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| TheraFirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Gary J. Richmond,M.D.,P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| Tarrant County Infectious Disease Associates | Miami | Florida | 33133 | — |
| AIDS Healthcare Foundation | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| AIDS Healthcare Foundation | Tampa | Florida | 33602 | — |
| AIDS Research & 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 School of Medicine | Macon | Georgia | 31201 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| The Kc Care Clinic Site 5580 | Kansas City | Missouri | 64111 | — |
| St. Louis University | St Louis | Missouri | 63110 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | — |
| New York Hospital Queens | Flushing | New York | 11355 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Ricky K. Hsu, MD, PC | New York | New York | 10011 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Infectious Disease Consultants, PA | Charlotte | North Carolina | 28209 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| AIDS Arms, Inc | Dallas | Texas | 75215 | — |
| Southwest Infectious Disease Clinical Research, Inc | Dallas | Texas | 75219 | — |
| North Texas Infectious Diseases Consulants | Dallas | Texas | 75246 | — |
| AIDS Arms, Inc./Trinity Health & Wellness Center | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Gordon E. Crofoot MD PA | Houston | Texas | 77098 | — |
| Peter Shalit, MD | Seattle | Washington | 98104 | — |
| Premier Clinical Research | Spokane | Washington | 99202 | — |
| 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 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02121795, 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 12, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02121795 live on ClinicalTrials.gov.