Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
2 other identifiers
interventional
632
12 countries
117
Brief Summary
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2016
CompletedResults Posted
Study results publicly available
December 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2019
CompletedJanuary 2, 2020
December 1, 2019
1.4 years
January 19, 2015
September 20, 2017
December 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 48
Secondary Outcomes (9)
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Week 48
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Week 96
Change From Baseline in CD4+ Cell Count at Week 48
Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Baseline; Week 96
- +4 more secondary outcomes
Study Arms (3)
FTC/RPV/TAF
EXPERIMENTALFTC/RPV/TAF plus FTC/RPV/TDF placebo for at least 96 weeks.
FTC/RPV/TDF
ACTIVE COMPARATORFTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks.
Open Label Extension Phase
EXPERIMENTALAfter the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF, and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Interventions
200/25/25 mg FDC tablets administered orally once daily
200/25/300 mg FDC tablets administered orally once daily
Eligibility Criteria
You may qualify if:
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Currently receiving FTC/RPV/TDF FDC for ≥ 6 consecutive months preceding the screening visit
- Documented plasma HIV-1 RNA levels \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA \< 50 copies/mL, single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed
- Have no documented resistance to any of the study agents at any time in the past
- HIV-1 RNA \< 50 copies/mL at the screening visit
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL (≤ 26 μmol/L), or normal direct bilirubin
- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3 (1.00 GI/L); platelets ≥ 50,000/mm\^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L))
- Serum amylase ≤ 5 × ULN (individuals with serum amylase \> 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
- Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (1.17 mL/sec) according to the Cockcroft-Gault formula
You may not qualify if:
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)
- Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Current alcohol or substance use judged by the Investigator to potentially interfere with individual's study compliance
- A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
- Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals with any known allergies to the excipients of FTC/RPV/TAF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (117)
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
AHF Research Center
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Long Beach Education and Research Consultants
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
Southern California Men's Medical Group
Los Angeles, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
Alameda County Medical Center
Oakland, California, United States
Desert Medical Group Inc., dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Kaiser Permanente
Sacramento, California, United States
University of California-UC Davis
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Optimus Medical
San Francisco, California, United States
Kaiser Permanente
San Leandro, California, United States
Los Angeles BioMedical Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Apex Research Institute
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
World Health Clinicians' CIRCLE CARE Center
Norwalk, Connecticut, United States
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
AIDS Healthcare Foundation
Miami, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Infectious Diseases Associates of NW Florida, P.A.
Pensacola, Florida, United States
Hillsborough County Health Dept.
Tampa, Florida, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Rowan Tree Medical PA
Wilton Manors, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Atlanta ID Group
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Brigham and Women's
Boston, Massachusetts, United States
Community Research Initiative
Boston, Massachusetts, United States
MetroWest Medical Center
Framingham, Massachusetts, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Upstate Infectious Diseases Associates
Albany, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center--Myers Park Infectious Disease Clinic
Charlotte, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
Fort Worth, Texas, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
Peter Shalit, MD
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CHU Saint-Pierre University Hospital
Brussels, Belgium
Cliniques Universitaires UCL Saint-Luc
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
University of Alberta
Edmonton, Alberta, Canada
Spectrum Health
Vancouver, British Columbia, Canada
Maple Leaf Research
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Clinique medicale l'Actuel
Montreal, Quebec, Canada
Clinique OPUS
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales
Montpellier, France
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
Berlin, 10439, Germany
University of Bonn
Bonn, Germany
Universitat zu Koln
Cologne, Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Infektiologikum
Frankfurt, Germany
Asklepios Klinik
Hamburg, Germany
ICH Study Center Hamburg
Hamburg, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
MUC Research GmbH
München, Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Fondazione IRCCS San Raffaele del Monte Tabor
Milan, Italy
Erasmus MC
Rotterdam, Netherlands
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico
Hope Clinical Research
San Juan, Puerto Rico
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitary de Bellvitge
Barcelona, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Karolinska Institutet
Stockholm, Sweden
University Hospital Basel
Basel, Switzerland
Geneva University Hospital
Geneva, Switzerland
NHS Greater Glasgow
Glasgow, United Kingdom
Barts & The London NHS Trust
London, United Kingdom
Chelsea & Westminster Hospital
London, United Kingdom
Mortimer Market Centre
London, United Kingdom
The Royal Free Hampstead NHS Trust
London, United Kingdom
The Hathersage Integrated Contraception, Sexual Health and HIV Service
Manchester, United Kingdom
Related Publications (12)
Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.
PMID: 30101539RESULTMills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections,Boston. March 4-7, 2018, Abstract 504.
RESULTArribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation atthe 16th European AIDS Conference, 2017 25-27 October Milan, Italy.
RESULTPorter DP, Kulkarni R, Cao H, SenGupta D, White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster1381]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.
RESULTWohl D, Kulkarni R, Garner W, White KL, Porter DL. Viral Blips Were Infrequent in HIV1-Infected Virologically-Suppressed Adults Treated with Tenofovir Alafenamide or Tenofovir DF Rilpivirine-Containing Regimens [Poster1384]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.
RESULTDeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Molina J-M, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshopon HIV and Aging 2017 2-3 October, New York, New York.
RESULTMolina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, Thalme A, et al. Efficacy and Odefsey® StudyGS-US-366-1216Final Synoptic Clinical Study Report Final CONFIDENTIAL Page4 30July2019 Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.
RESULTRockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science;2017 23-26July Paris, France.
RESULTOrkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.
PMID: 28259777RESULTMajeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, WA.
RESULTHagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching toRPV/FTC/TAF in Women [Abstract12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.
RESULTOrkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study1160) or RPV/FTC/TDF (Study1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2015
First Posted
January 26, 2015
Study Start
January 26, 2015
Primary Completion
June 22, 2016
Study Completion
January 9, 2019
Last Updated
January 2, 2020
Results First Posted
December 8, 2017
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.