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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 Oct 17, 2026, 12:28 AM 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 27, 2013 (Actual)
Primary completion
Mar 16, 2015 (Actual)
Completion
Apr 1, 2020 (Actual)
Last update posted
Apr 13, 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 13, 2021 · 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 NCT01815736 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →