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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01815736

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.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 5:20 PM EDT

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
Lead sponsor
Gilead Sciences
Industry
Enrollment
1,443 participants

Conditions and interventions

Interventions

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
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.

View official ClinicalTrials.gov record →