Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
NCT ID: NCT02345226
Last Updated: 2020-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
881 participants
INTERVENTIONAL
2015-01-26
2019-01-02
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FTC/RPV/TAF
FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks.
FTC/RPV/TAF
200/25/25 mg FDC tablets administered orally once daily
EFV/FTC/TDF Placebo
Tablets administered orally once daily
EFV/FTC/TDF
EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks.
EFV/FTC/TDF
600/200/300 mg FDC tablets administered orally once daily
FTC/RPV/TAF Placebo
Tablets administered orally once daily
Open Label Extension Phase
After the Week 96 visit, 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 elects to discontinue the study, whichever occurs first.
FTC/RPV/TAF
200/25/25 mg FDC tablets administered orally once daily
Interventions
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FTC/RPV/TAF
200/25/25 mg FDC tablets administered orally once daily
EFV/FTC/TDF Placebo
Tablets administered orally once daily
EFV/FTC/TDF
600/200/300 mg FDC tablets administered orally once daily
FTC/RPV/TAF Placebo
Tablets administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently receiving EFV/FTC/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. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
* 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, or normal direct bilirubin
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
* 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 according to the Cockcroft-Gault formula
Exclusion Criteria
* 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 the 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Maricopa Integrated Health System
Phoenix, Arizona, 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
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
Medical Faculty Associates, Inc.
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
University of Miami
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
Mercer University School of Medicine
Macon, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
The CORE Foundation
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Boston University Medical Center
Boston, Massachusetts, United States
Brigham and Women's
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
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
North Shore University Hospital
Manhasset, New York, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Infectious Disease Consultants, PA
Charlotte, North Carolina, United States
The Brody School of Medicine
Greenville, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, 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
Southwest Infectious Disease Clinical Research, Inc.
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
CHU Saint-Pierre University Hospital
Brussels, , Belgium
Cliniques Universitaires UCL Saint-Luc
Brussels, , Belgium
University of Alberta
Edmonton, Alberta, Canada
Spectrum Health
Vancouver, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, 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
Hopital Bichat Claude Bernard
Paris, , France
Hopital Saint Louis
Paris, , France
Chu Tours
Tours, , France
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
Berlin, , 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
ICH Study Center Hamburg
Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
MUC Research GmbH
München, , Germany
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
Hope Clinical Research
San Juan, , Puerto Rico
University of Puerto Rico School of Medicine
San Juan, , Puerto Rico
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitary de Bellvitge
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
University Hospital Basel
Basel, , Switzerland
Geneva University Hospital
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Barts & The London NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Mortimer Market Centre
London, , United Kingdom
The Royal Free Hampstead NHS Trust
London, , United Kingdom
Countries
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References
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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.
Mills 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.
Arribas 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): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy.
Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California.
E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York.
Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and 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.
Rockstroh 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 26 July Paris, France.
DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and 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):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2.
Majeed 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 [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington.
Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.
Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.
Other Identifiers
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2014-004779-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-366-1160
Identifier Type: -
Identifier Source: org_study_id
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