Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Public ClinicalTrials.gov record NCT01815736. 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 a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.
Study identification
- NCT ID
- NCT01815736
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,443 participants
Conditions and interventions
Conditions
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
- Mar 26, 2013
- Primary completion
- Mar 15, 2015
- Completion
- Mar 31, 2020
- Last update posted
- Apr 12, 2021
2013 – 2020
United States locations
- U.S. sites
- 91
- U.S. states
- 26
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Southwest Center for HIV/AIDS | Phoenix | Arizona | 85006 | — |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Health for Life Clinic PLLC | Little Rock | Arkansas | 72207 | — |
| AHF Research Center | Beverly Hills | California | 90211 | — |
| Michael Keith Wensley, MD, Inc., A Medical Corporation | Costa Mesa | California | 92626 | — |
| Living Hope Clinical Foundation | Long Beach | California | 90813 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90028 | — |
| 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 | — |
| Alameda County Medical Center | Oakland | California | 94602 | — |
| East Bay AIDS Center | Oakland | California | 94609 | — |
| Stanford University | Palo Alto | California | 94303 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolis Medical Group | San Francisco | California | 94109 | — |
| Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California | 94118 | — |
| Kaiser Permanente Hospital | San Leandro | California | 94577 | — |
| Apex Research LLC | Denver | Colorado | 80209 | — |
| Greenwich Hospital | Greenwich | Connecticut | 06830 | — |
| Yale University HIV Clinical Trials Program | New Haven | Connecticut | 06510 | — |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Broward Health/Comprehensive Care Center | Fort Lauderdale | Florida | 33311 | — |
| Gary J. Richmond,M.D.,P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| IDOCF/ Value Health MD, LLC | Orlando | Florida | 32806 | — |
| University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | Tampa | Florida | 33602 | — |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33615 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University School of Medicine | Macon | Georgia | 31201 | — |
| University of Hawaii - Hawaii Center for AIDS | Honolulu | Hawaii | 96816 | — |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| NorthStar Medical Center | Chicago | Illinois | 60657 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02111 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
| Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts | 01199 | — |
| 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 | St Louis | Missouri | 63108 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Southampton Healthcare | St Louis | Missouri | 63139 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| SouthWest CARE Center | Santa Fe | New Mexico | 87505 | — |
| Upstate ID Association | Albany | New York | 12208 | — |
| Albany Medical College | Albany | New York | 12209 | — |
| New York Hospital Queens | Flushing | New York | 11355 | — |
| North Shore University Hospital, Divison of Infectious Diseases | Manhasset | New York | 11030 | — |
| Greiger Clinic | Mount Vernon | New York | 10550 | — |
| Beth Israel Medical Center- Division of Infectious Diseases | New York | New York | 10003 | — |
| Chelsea Village Medical, PC | New York | New York | 10011 | — |
| Ricky K. Hsu, MD | New York | New York | 10011 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - AIDS Center | The Bronx | New York | 10467 | — |
| University of NC AIDS Clinical Trials Unit | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center-Myers Park | Charlotte | North Carolina | 28207 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | — |
| AIDS Arms, Inc./ Peabody Health Center | Dallas | Texas | 75215 | — |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Garcia's Family Health Group | Harlingen | Texas | 78550 | — |
| Therapeutic Concepts, P.A. | Houston | Texas | 77004 | — |
| Gordon E. Crofoot MD PA | Houston | Texas | 77098 | — |
| Research Access Network | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID) | Annandale | Virginia | 22003 | — |
| Peter Shalit, M.D. | 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 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01815736, 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 12, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01815736 live on ClinicalTrials.gov.