Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
1 other identifier
interventional
707
2 countries
102
Brief Summary
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv
Started Mar 2010
Longer than P75 for phase_3 hiv
102 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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedResults Posted
Study results publicly available
October 22, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 11, 2015
October 1, 2015
1.4 years
March 17, 2010
September 20, 2012
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
Week 48
Secondary Outcomes (6)
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
Week 96
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
Week 144
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192
Week 192
The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
Week 48
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Baseline; Weeks 48, 96, 144, and 192
- +1 more secondary outcomes
Study Arms (2)
Stribild
EXPERIMENTALStribild plus placebo to match Atripla
Atripla
ACTIVE COMPARATORAtripla plus placebo to match Stribild
Interventions
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime
Placebo to match Atripla tablet administered orally once daily prior to bedtime
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 ≥ 5,000 copies/mL
- No prior use of any approved or investigational antiretroviral drug for any length of time
- Screening genotype report must show sensitivity to FTC, TDF, and EFV
- Normal electrocardiogram (ECG)
- Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 5 x the upper limit of the normal range (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug
- Age ≥ 18 years
- Life expectancy ≥ 1 year
You may not qualify if:
- A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
- Subjects experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject 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
- Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla tablets
- Participation in any other clinical trial without prior approval
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (102)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Spectrum Medical Group
Phoenix, Arizona, 85012, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, 72207, United States
AHF Research Center
Beverly Hills, California, 90211, United States
Kaiser Permanente Hospital
Hayward, California, 94545, United States
Living Hope Clinical Foundation
Long Beach, California, 90813, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90028, United States
UCLA Center for Clinical Aids Research and Education
Los Angeles, California, 90035, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Anthony Mills, MD, Inc.
Los Angeles, California, 90069, United States
Orange Coast Medical Group
Newport Beach, California, 92663, United States
Alameda County Medical Center
Oakland, California, 94602, United States
East Bay AIDS Center
Oakland, California, 94609, United States
Stanford University
Palo Alto, California, 94303, United States
Kaiser Permanente Medical Group
Sacramento, California, 95825, United States
La Playa Medical Group and Clinical Research
San Diego, California, 92103, United States
San Francisco General Hospital, University of California, San Francisco
San Francisco, California, 94110, United States
Metropolis Medical
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, 94118, United States
Apex Research, LLC
Denver, Colorado, 80209, United States
Yale University HIV Clinical Trials Program
New Haven, Connecticut, 06033, United States
The Stamford Hospital
Stamford, Connecticut, 06902, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, 33311, United States
Gary J. Richmond, MD, PA
Fort Lauderdale, Florida, 33316, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
The Kinder Medical Group
Miami, Florida, 33133, United States
University of Miami School of Medicine
Miami, Florida, 33136, 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
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida, 33602, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, 33614, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, 33615, United States
Treasure Coast Infectious Disease Consultants
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 Specialists of Atlanta
Decatur, Georgia, 30033, United States
Mercer University School of Medicine
Macon, Georgia, 31210, United States
Leahi Hospital
Honolulu, Hawaii, 96816, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Community Research Initiative
Boston, Massachusetts, 02215, United States
The Research Institute
Springfield, Massachusetts, 01107, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, 01199, 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
St Louis, Missouri, 63108, United States
Southampton Healthcare
St Louis, Missouri, 63139, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Garden State Infectious Diseases Associates, PA
Voorhees Township, New Jersey, 08043, United States
SouthWest CARE Center
Sante Fe, New Mexico, 87505, United States
Upstate ID Association
Albany, New York, 12208, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Hospital Queens
Flushing, New York, 11355, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Greiger Clinic
Mount Vernon, New York, 10550, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Chelsea Village Medical, PC
New York, New York, 10011, United States
Ricky K. Hsu, MD, PC
New York, New York, 10011, United States
The Aaron Diamond AIDS Research Center
New York, New York, 10016, United States
Montefiore Medical Center - AIDS Center
The Bronx, New York, 10467, United States
Jacobi Medical Center
The Bronx, New York, 31210, United States
Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center-Myers Park
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Health System
Akron, Ohio, 44304, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75204, United States
Peabody Health Center
Dallas, Texas, 75215, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Valley AIDS Council
Harlingen, Texas, 78550, United States
Therapeutic Concepts
Houston, Texas, 77004, United States
Gordon E. Crofoot MD PA
Houston, Texas, 77098, United States
Research Access Network
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
Annandale, Virginia, 22003, United States
Peter Shalit, MD
Seattle, Washington, 98104, United States
Rockwood Pulmonary and Critical Care
Spokane, Washington, 99204, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Instituto de Investigacion Clentifica del Sur
Ponce, 00731, Puerto Rico
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
HOPE Clinical Research
San Juan, 00909, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
University of Puerto Rico, School of Medicine, Proyecto ACTU
San Juan, 00935, Puerto Rico
Related Publications (3)
Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, Gallant JE, Liu HC, Zhong L, Yale K, White K, Kearney BP, Szwarcberg J, Quirk E, Cheng AK; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012 Jun 30;379(9835):2439-2448. doi: 10.1016/S0140-6736(12)60917-9.
PMID: 22748591RESULTZolopa A, Sax PE, DeJesus E, Mills A, Cohen C, Wohl D, Gallant JE, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 May 1;63(1):96-100. doi: 10.1097/QAI.0b013e318289545c.
PMID: 23392460RESULTWohl DA, Cohen C, Gallant JE, Mills A, Sax PE, Dejesus E, Zolopa A, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e118-20. doi: 10.1097/QAI.0000000000000057. No abstract available.
PMID: 24256630RESULT
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, Inc.
Study Officials
- STUDY DIRECTOR
Martin Rhee, MD
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 30, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2011
Study Completion
September 1, 2014
Last Updated
November 11, 2015
Results First Posted
October 22, 2012
Record last verified: 2015-10