Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
NCT ID: NCT01797445
Last Updated: 2020-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
872 participants
INTERVENTIONAL
2013-03-12
2018-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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E/C/F/TAF (Double-Blind)
E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks
After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
E/C/F/TDF Placebo
Tablet administered orally once daily
E/C/F/TDF (Double-Blind)
E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks
After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
E/C/F/TAF Placebo
Tablet administered orally once daily
Open-Label E/C/F/TAF
After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
Interventions
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E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
E/C/F/TDF Placebo
Tablet administered orally once daily
E/C/F/TAF Placebo
Tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
* Age ≥ 18 years
Exclusion Criteria
* 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
* Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States
Peter J. Ruane, Inc.
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Alameda County Medical Center
Oakland, California, United States
Stanford University
Palo Alto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Kaiser Permanente
San Leandro, California, United States
Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
APEX Research LLC
Denver, Colorado, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
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
Idocf/Valuhealthmd
Orlando, Florida, United States
Infectious Diseases Associates of NW FL
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Atlanta ID Group, PC
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States
Mercer University
Macon, Georgia, United States
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States
Rush University Medical Center, Section of Infectious Diseases
Chicago, Illinois, United States
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
The Research Institute
West 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
Central West Clinical Research
St Louis, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
ID Care
Hillsborough, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Albany Medical College
Albany, New York, United States
Upstate ID Assoc
Albany, New York, United States
North Shore University Hospital - Division of Infectious Diseases
Manhasset, New York, United States
Chelsea Village Medical
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
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 AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States
Carolinas Medical Center Myer's Park Clinic
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University The Brody School of Medicine
Greenville, North Carolina, United States
Rosedale Infectious Disseases
Huntersville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Central Texas Clinical Research
Austin, Texas, United States
St. Hope Foundation, Inc.
Bellaire, Texas, United States
Trinity Health & Wellness Center / AIDS Arms, Inc.
Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, 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 (CARE-ID)
Annandale, Virginia, United States
Peter Shalit, MD
Seattle, Washington, United States
Research Institute of McGill University Health Care
Montreal, Quebec, Canada
Clinique Medicale L'actuel
Montreal, , Canada
University Health Network/Toronto General Hospital
Toronto, , Canada
Maple Leaf Research
Toronto, , Canada
Spectrum Health Care
Vancouver, , Canada
Instituto Dominicano de Estudios Virologicos--IDEV
Santo Domingo, , Dominican Republic
Hopital de la Croix Rousse
Lyon, , France
University Hospital of Montpellier (CHU-Gui de Chauliac)
Montpellier, , France
Archet 1 CHU de Nice, Department of Infectiology
Nice, , France
Saint Louis Hospital of Infectious Diseases
Paris, , France
Hopital Saint Antoine
Paris, , France
Hôpital Bichat Claude Bernard
Paris, , France
Hopital Tenon
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
CH Tourcoing
Tourcoing, , France
Universitaria di Bologna-Policlicnico S' Orsola Malpighi
Bologna, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Hospital Civil de Guadalajara
Guadalajara, , Mexico
Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"
Mexico City, , Mexico
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Serviço de Doenças Infecciosas, HUC-CHUC, EPE
Coimbra, , Portugal
Hospital Santo Antonio dos Capuchos
Lisbon, , Portugal
Hospital de Santa Maria - CHLN, EPE
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, , Portugal
Hope Clinical Research
San Juan, , Puerto Rico
University of Puerto Rico ACTU
San Juan, , Puerto Rico
Venhalsan / Sodersjukhuset
Stockholm, , Sweden
Karolinska University Hospital, Huddinge
Stockholm, , Sweden
Whittall Street Clinic
Birmingham, , United Kingdom
Heart Of England NHS Foundation Trust
Birmingham, , United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Brownlee Centre, Gartnavel General Hospital
Glasgow, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Chelsea and Westminster
London, , United Kingdom
Mortimer Market Centre
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Countries
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References
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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.
Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.
Arribas 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.
Margot 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.
Margot 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.
Funderburg 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.
Wohl 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.
Custodio 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.
Other Identifiers
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2013-000102-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-292-0111
Identifier Type: -
Identifier Source: org_study_id
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