Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
Public ClinicalTrials.gov record NCT03110380. 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 Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
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 switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
Study identification
- NCT ID
- NCT03110380
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 567 participants
Conditions and interventions
Conditions
Interventions
- B/F/TAF Drug
- F/TAF Drug
- DTG Drug
- DTG Placebo Drug
- F/TAF Placebo Drug
- B/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
- Jun 12, 2017 (Actual)
- Primary completion
- Dec 4, 2018 (Actual)
- Completion
- Feb 10, 2021 (Actual)
- Last update posted
- Jan 11, 2022
2017 – 2021
United States locations
- U.S. sites
- 66
- U.S. states
- 19
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| Highland Hospital - Alameda Health System | Oakland | California | 94602 | — |
| Cares Community Health | Sacramento | California | 95814 | — |
| Kaiser Permanente | Sacramento | California | 95825 | — |
| Hepatitis/HIV Clinical Trials Group (HHCTG) | San Francisco | California | 94110 | — |
| Kaiser Permanente | San Francisco | California | 94118 | — |
| Kaiser Permanente, Department of Infectious Diseases | San Leandro | California | 94577 | — |
| University of Colorado Denver, University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Whitman-Walker Institute | Washington D.C. | District of Columbia | 20005 | — |
| Dupont Circle Physician's Group | Washington D.C. | District of Columbia | 20009 | — |
| Providence Hospital Center for Infectious Diseases | Washington D.C. | District of Columbia | 20017 | — |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| 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 | — |
| University of Miami Divison of Infectious Diseases Clinical Research Unit | Miami | Florida | 33136 | — |
| AIDS Healthcare Foundation - South Beach | Miami Beach | Florida | 33140 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| AHF-Pensacola | Pensacola | Florida | 32503 | — |
| Infectious Disease Research Institute Inc | Tampa | Florida | 33614 | — |
| St. Joseph's Hospital Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| AIDS Research and Treatment Center of the Treasure Coast | Vero Beach | Florida | 32960 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | — |
| Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30312 | — |
| AU Medical Center | Augusta | Georgia | 30912 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University, Department of Internal Medicine | Macon | Georgia | 31201 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako | Honolulu | Hawaii | 96813 | — |
| University of Louisville 550 Clinic | Louisville | Kentucky | 40202 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02129 | — |
| Metro West Medical Center | Framingham | Massachusetts | 01702 | — |
| Claudia T Martorell, MD., LLC d/b/a The Research Institute | Springfield | Massachusetts | 01105 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Abbott Northwestern Hospital part of Allina Health | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center, Positive Care Clinic | Minneapolis | Minnesota | 55415 | — |
| Kansas City CARE Clinic | Kansas City | Missouri | 64111 | — |
| 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 | — |
| Southwest CARE Center | Albuquerque | New Mexico | 87109 | — |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | — |
| North Shore University Hospital/Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Duke University Heath System | Durham | North Carolina | 27710 | — |
| East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care | Greenville | North Carolina | 27834 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Palmetto Health Richland (Regulatory and Study Supply Shipping) | Columbia | South Carolina | 29203 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| AIDS Arms Inc/ Trinity Health and Wellness Center | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Research Access Network | Houston | Texas | 77098 | — |
| The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Peter Shalit, M.D. | Seattle | Washington | 98104 | — |
| MultiCare Rockwood HIV Critical Care Clinic | Spokane | Washington | 99204 | — |
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 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03110380, 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 Jan 11, 2022 · Synced Oct 25, 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 NCT03110380 live on ClinicalTrials.gov.