Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC
2 other identifiers
interventional
567
12 countries
80
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Typical duration for phase_3
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
June 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2017
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedOctober 25, 2019
October 1, 2019
2.5 years
June 9, 2015
March 29, 2018
October 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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 (11)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Week 96
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Week 48
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Week 96
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Week 48
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Week 96
- +6 more secondary outcomes
Study Arms (3)
F/TAF (Double-Blind)
EXPERIMENTALF/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
ABC/3TC (Double-Blind)
ACTIVE COMPARATORABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
Open-Label F/TAF
EXPERIMENTALAfter the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
Interventions
200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily
An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).
Eligibility Criteria
You may qualify if:
- The ability to understand and sign a written informed consent form
- On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening
- Plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
- Plasma HIV-1 RNA should be \< 50 copies/mL at the screening visit
- Normal ECG
- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
You may not qualify if:
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Individuals experiencing decompensated cirrhosis
- Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
- Pregnant or lactating females
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the investigator to potentially interfere with 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.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
- 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
- Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (80)
Spectrum Medical Group
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
University of California San Diego (UCSD)
La Jolla, California, United States
Anthony Mills, MD, Inc.
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Highland Hospital - Alameda Health System
Oakland, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Capial Medical Associates
Washington D.C., District of Columbia, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Be Well Medical Center
Berkley, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
The KC CARE Clinic
Kansas City, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 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
Montefiore Medical Center
The Bronx, New York, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
AIDS Arms, Inc
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Peter Shalit, MD
Seattle, Washington, United States
UZ Gent
Ghent, Belgium
Centre Hospitalier Universitaire CHU Sart Tilman Liege
Liège, Belgium
Clinique medicale l'Actuel
Montreal, Canada
Maple Leaf Research
Toronto, Canada
Spectrum Health
Vancouver, Canada
Vancouver ID Research and Care Centre Society
Vancouver, Canada
Hvidovre Hospital
Copenhagen, Denmark
CHU - Groupe Saint-Andre
Bordeaux, France
CHU de Bordeaux
Bordeaux, France
C.H.U. de Nantes
Nantes, France
CHR Orleans la Source
Orléans, France
Chu Tours
Tours, France
ICH Study Center Hamburg
Bielefeld, Germany
Medizinische Universitatsklinik
Bonn, Germany
Klinikum der Universitaet Koln
Cologne, Germany
Universitatsklinikum Essen
Essen, Germany
Johann Wolfgang Goethe-University Hospital
Frankfurt, Germany
ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg
Hamburg, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum München
Munich, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
Saint James's Hospital
Dublin, Ireland
University of Brescia
Brescia, Italy
Azienda Ospedaliera Luigi Sacco
Milan, Italy
Fondazione IRCCS San Raffaele del Monte Tabor
Milan, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma, Italy
Ospedale Amedeo di Savoia - Specializzato Malattie infettive
Torino, Italy
Clinical Research Puerto Rico
San Juan, Puerto Rico
Hope Clinical Research Inc
San Juan, Puerto Rico
Bonaventura
Badalona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Costa Del Sol
Málaga, Spain
Karolinska University Hospital
Stockholm, Sweden
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Imperial College
London, United Kingdom
Kings College Hospital NHS Trust
London, United Kingdom
Lewisham and Greenwich NHS Trust
London, United Kingdom
Royal Free Hospital
London, United Kingdom
St. George's Hospital
London, United Kingdom
Manchester Centre for Sexual Health
Manchester, United Kingdom
Related Publications (2)
Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.
PMID: 29475804RESULTGupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.
PMID: 30932951RESULT
MeSH Terms
Interventions
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 11, 2015
Study Start
June 29, 2015
Primary Completion
December 11, 2017
Study Completion
March 13, 2019
Last Updated
October 25, 2019
Results First Posted
June 11, 2018
Record last verified: 2019-10
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.