Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
NCT ID: NCT01497899
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2011-12-28
2016-08-22
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
E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks
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
E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks
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
E/C/F/TAF Open-Label
Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase.
Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
* No prior use of any approved or experimental anti-HIV drug for any length of time
* Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)
* Normal ECG
* Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
* Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* CD4+ cell count \> 50 cells/µL
* Serum amylase ≤ 5 x ULN
* Normal thyroid-stimulating hormone (TSH)
* Females of childbearing potential must have a negative serum pregnancy test
* Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs
* Female subjects 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
* Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
* Female subjects 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 test at screening
* Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product
* Age ≥ 18 years
* Life expectancy ≥ 1 year
Exclusion Criteria
* Hepatitis B surface Antigen positive
* Hepatitis C Antibody positive
* Proven acute hepatitis in the 30 days prior to study entry
* Subjects experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Have an implanted defibrillator or pacemaker
* Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
* Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
* Current alcohol or substance
* History of or ongoing malignancy (including untreated carcinoma in-situ) 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 Baseline
* Participation in any other clinical trial without prior approval is prohibited while participating in this trial
* Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
* Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC tablets
* Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
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 (UAB)
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
AHF Research Center
Beverly Hills, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
East Bay AIDS Center
Oakland, California, United States
St. Joseph Heritage Healthcare
Orange, California, United States
Stanford University
Palo Alto, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Metropolis Medical
San Francisco, California, United States
Kaiser Permanente Medical Group-Clinical Trials Unit
San Francisco, California, United States
Apex Research, LLC
Denver, Colorado, 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
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ValuhealthMD, LLC
Orlando, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University Mercer Medicine
Macon, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, 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 Inc
St Louis, Missouri, United States
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, United States
ID Consultants, P.A.
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of South Carolina School of Medicine Division of Infectious Disease
Columbia, South Carolina, United States
Southwest Infectious Disease Clinical Research Inc
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
DCOL Center for Clinical Research
Longview, Texas, United States
Peter Shalit, M.D.
Seattle, Washington, United States
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Sax PE, Zolopa A, Brar I, Elion R, Ortiz R, Post F, Wang H, Callebaut C, Martin H, Fordyce MW, McCallister S. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):52-8. doi: 10.1097/QAI.0000000000000225.
Other Identifiers
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GS-US-292-0102
Identifier Type: -
Identifier Source: org_study_id
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