Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
1 other identifier
interventional
279
2 countries
41
Brief Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, 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_2
Started Dec 2011
Longer than P75 for phase_2
41 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
December 14, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedStudy Start
First participant enrolled
December 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2012
CompletedResults Posted
Study results publicly available
January 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2016
CompletedNovember 19, 2018
August 1, 2017
10 months
December 14, 2011
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 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 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 24
Secondary Outcomes (3)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Week 48
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Baseline; Weeks 24 and 48
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Baseline; Weeks 24 and 48
Study Arms (3)
E/C/F/TAF
EXPERIMENTALE/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks
E/C/F/TDF
ACTIVE COMPARATORE/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks
E/C/F/TAF Open-Label
EXPERIMENTALFollowing 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.
Interventions
Eligibility Criteria
You may qualify if:
- Ability to understand and sign a written informed consent form
- 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
- +5 more criteria
You may not qualify if:
- New AIDS-defining condition diagnosed within the 30 days prior to screening
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (41)
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233, United States
Spectrum Medical Group
Phoenix, Arizona, 85012, United States
AHF Research Center
Beverly Hills, California, 90211, United States
Kaiser Permanente
Los Angeles, California, 90027, 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
St. Joseph Heritage Healthcare
Orange, California, 92869, United States
Stanford University
Palo Alto, California, 94304, United States
Kaiser Permanente Medical Group
Sacramento, California, 95825, United States
La Playa Medical Group and Clinical Research
San Diego, California, 92103, United States
Metropolis Medical
San Francisco, California, 94107, United States
Kaiser Permanente Medical Group-Clinical Trials Unit
San Francisco, California, 94118, United States
Apex Research, LLC
Denver, Colorado, 80220, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Whitman-Walker Health
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, 33316, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
IDOCF/ValuhealthMD, LLC
Orlando, Florida, 32806, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, 33614, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Mercer University Mercer Medicine
Macon, Georgia, 31201, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Henry Ford Health System
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
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, 11030, United States
ID Consultants, P.A.
Charlotte, North Carolina, 28209, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of South Carolina School of Medicine Division of Infectious Disease
Columbia, South Carolina, 29203, United States
Southwest Infectious Disease Clinical Research Inc
Dallas, Texas, 75219, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, 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
Peter Shalit, M.D.
Seattle, Washington, 98104, United States
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
Related Publications (1)
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.
PMID: 24872136RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no limitations affecting the analysis or results.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- 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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2011
First Posted
December 23, 2011
Study Start
December 28, 2011
Primary Completion
October 17, 2012
Study Completion
August 22, 2016
Last Updated
November 19, 2018
Results First Posted
January 8, 2016
Record last verified: 2017-08
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.