Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
2 other identifiers
interventional
872
11 countries
112
Brief Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv
Started Dec 2012
Longer than P75 for phase_3 hiv
112 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
Study Start
First participant enrolled
December 26, 2012
CompletedFirst Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2014
CompletedResults Posted
Study results publicly available
January 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2017
CompletedNovember 19, 2018
August 1, 2018
1.7 years
January 16, 2013
December 4, 2015
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the 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 (23)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144
Weeks 96 and 144
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
Weeks 48, 96. and 144
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
Change From Baseline in CD4+ Cell Count at Week 144
Baseline; Week 144
- +18 more secondary outcomes
Study Arms (3)
E/C/F/TAF (Double-Blind Phase)
EXPERIMENTALE/C/F/TAF plus E/C/F/TDF placebo for 144 weeks
E/C/F/TDF (Double-Blind Phase)
ACTIVE COMPARATORE/C/F/TDF plus E/C/F/TAF placebo for 144 weeks
Open-Label Extension Phase
EXPERIMENTALAfter study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.
Interventions
Eligibility Criteria
You may qualify if:
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening
- Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
- Normal electrocardiogram (ECG)
- Estimated glomerular filtration rate (eGFR) ≥ 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
- Males and females of childbearing potential 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
- Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
You may not qualify if:
- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive
- Individuals experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
- History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- 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
- Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (117)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Spectrum Medical Group
Phoenix, Arizona, 85012, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
University of California, Los Angeles
Los Angeles, California, 90035, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Anthony Mills MD Inc
Los Angeles, California, 90069, United States
East Bay AIDS Center
Oakland, California, 94609, United States
Kaiser Permanente - Sacramento
Sacramento, California, 95825, United States
La Playa Medical Group and Clinical Research
San Diego, California, 92103, United States
University of California, San Diego
San Diego, California, 92103, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Apex Research, LLC
Denver, Colorado, 80209, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Dupont Circle Physicians Group, P.C.
Washington D.C., District of Columbia, 20009, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, 20036, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, 33316, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, 34982, United States
The Kinder Medical Group
Miami, Florida, 33133, United States
AIDS Healthcare Foundation
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
IDOCF/ValuHealthMD, LLC
Orlando, Florida, 32806, United States
Infectious Diseases Associates
Pensacola, Florida, 32504, United States
The University of South Florida
Tampa, Florida, 33602, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, 33614, United States
St. Joseph's Comprenhensive Research Inisitute
Tampa, Florida, 33614, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Emory University
Atlanta, Georgia, 30308, United States
Atlanta ID Group, PC
Atlanta, Georgia, 30309, United States
Infectious Disease Specialist of Atlanta
Decatur, Georgia, 30033, United States
Mercer University School of Medicine
Macon, Georgia, 31201, United States
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, 96816, United States
Northwestern University
Chicago, Illinois, 60611, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201, United States
Community Research Initative
Boston, Massachusetts, 02111, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Metrowest Medical Center
Framingham, Massachusetts, 01702, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, 01199, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Central West Clinical Research, Inc.
St Louis, Missouri, 63108, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505, United States
Albany Medical College
Albany, New York, 12208, United States
Upstate Infectious Diseases Associates
Albany, New York, 12208, United States
New York Hospital Queens
Flushing, New York, 11355, United States
North Shore University Hospital - Division of Infectious Diseases
Manhasset, New York, 11030, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Infectious Disease Consultants, PA
Charlotte, North Carolina, 28209, United States
Duke University
Durham, North Carolina, 22710, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Summa Health Care Center
Akron, Ohio, 44304, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
St. Hope Foundation, Inc.
Bellaire, Texas, 77401, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, 75208, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Garcias' Family Health Group
Harlingen, Texas, 78550, United States
Therapeutic Concepts, PA
Houston, Texas, 77004, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003, United States
Peter Shalit, MD
Seattle, Washington, 98104, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
Taylor Square Private Clinic
Darlington, New South Wales, 2010, Australia
East Sydney Doctors
Sydney, New South Wales, 2010 NSW, Australia
Albion Street Centre
Sydney, Southwest, 2010, Australia
Melbourne Sexual Health Clinic
Carlton, Victoria, 3053, Australia
DIAID, Department of Dermatology, Medical University Vienna
Vienna, 1090, Austria
Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
Vienna, 1140, Austria
Hôpital Erasme-ULB
Anderlecht, Brussels Capital, 1070, Belgium
CHU Saint-Pierre University Hospital
Brussels, 1000, Belgium
Spectrum Health
Vancouver, British Columbia, V6Z 2T1, Canada
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Maple Leaf Research
Toronto, Ontario, M5G 1K2, Canada
Clinique Medicale Du Quartier Latin
Montreal, Quebec, H2L 5B1, Canada
Clinique medicale l'Actuel
Montreal, Quebec, H2L 5B1, Canada
Clinique OPUS
Montreal, Quebec, H3A 1T1, Canada
Sunnybrook Health Science Center
Toronto, M4N 3M5, Canada
Ospedale San Raffaele
Milan, 20127, Italy
National Center for Global Health and Medicine AIDS Clinical Center
Shinjuku-ku, Tokyo, 162-8655, Japan
HOPE Clinical Research
San Juan, 00909, Puerto Rico
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
University Hospital Bellvitge
Barcelona, 08907, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, 15706, Spain
Universitätsspital Bern
Bern, 3010, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
University Hospital, Zurich
Zurich, CH-8091, Switzerland
The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
Bangkok, 10330, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University
Chiang Mai, 50200, Thailand
Khon Kaen University
Khon Kaen, 40002, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000, Thailand
Chelsea & Westminster Hospital
London, SW10 9TH, United Kingdom
Related Publications (7)
Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15.
PMID: 25890673RESULTArribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.
PMID: 28282300RESULTMargot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.
PMID: 28076335RESULTMargot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.
PMID: 26892863RESULTFunderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.
PMID: 27742226RESULTWohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.
PMID: 26829661RESULTCustodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 31, 2013
Study Start
December 26, 2012
Primary Completion
August 26, 2014
Study Completion
September 6, 2017
Last Updated
November 19, 2018
Results First Posted
January 8, 2016
Record last verified: 2018-08
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.