Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada 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 Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
1 other identifier
interventional
708
16 countries
138
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 ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of 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 P50-P75 for phase_3 hiv
Started Apr 2010
Typical duration for phase_3 hiv
138 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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 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
April 14, 2010
September 20, 2012
October 9, 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
EXPERIMENTALATV/r + FTC/TDF
ACTIVE COMPARATORInterventions
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
Ritonavir (RTV; /r) 100 mg tablet administered orally once daily
FTC/TDF 200/300 mg tablet administered orally once daily
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 at screening
- 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 ATV
- 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 30 days 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, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir 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 (146)
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
CSI Clinical Trials, Inc.
Costa Mesa, California, 92626, United States
Apex Research, LLC
Denver, California, 80209, 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
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
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente Medical Group
Sacramento, California, 95825, United States
La Playa Medical Group and Clinical Research
San Diego, California, 92103, United States
Metropolitan Medical
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, 94118, United States
National Jewish Health
Denver, Colorado, 80206, 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,M.D., P.A.
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
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
IDOCF/ ValueHealthMD, 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
Infectious Disease Solutions, PC
Atlanta, Georgia, 30309, 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
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
CentralWest Clinical Research
St Louis, Missouri, 63108, United States
Division of Infectious Diseases, St. Louis University Medical Center
St Louis, Missouri, 63110, 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
Upstate ID Association
Albany, New York, 12208, United States
Albany Medical College
Albany, New York, 12209, United States
STAR Health Care Center (SUNY Downstate)
Brooklyn, New York, 11203, 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
AIDS Care
Rochester, New York, 14604, United States
Montiefiore Medical Center- AIDS Center
The Bronx, New York, 10467, 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
Division of Infectious Diseases, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)
Dallas, Texas, 75204, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, 75208, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Garcia's Family Health Group
Harlingen, Texas, 78550, United States
Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)
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, M.D.
Seattle, Washington, 98104, United States
Holdsworth House Medical practice
Darlinghurst, New South Wales, 2010, Australia
National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales
Darlinghurst, New South Wales, 2010, Australia
Albion Street Centre
Sydney, New South Wales, 2010, Australia
East Sydney Doctors
Sydney, New South Wales, 2010, Australia
Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)
Carlton, Victoria, 3053, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Northside Clinic
Melbourne, Victoria, 3068, Australia
Taylor Square Private Clinica
Darlinghurst, N.S.W. 2011, Australia
LKH Graz West
Graz, A-8010, Austria
Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna
Vienna, 1090, Austria
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, 1140, Austria
CHU Saint-Pierre University Hospital
Brussels, 1000, Belgium
Hôpital Universitaire Erasme - ULB
Brussels, 1070, Belgium
University of Ghent
Ghent, 9000, Belgium
Southern Alberta Clinic
Calgary, Alberta, T2R0X7, Canada
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, M5B1L6, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Clinique medicale l'Actuel
Montreal, Quebec, H2L 4P9, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, H2L 5B1, Canada
Epidemiklinikken 5112, Rigshospitalet
Copenhagen, 2000, Denmark
Service des Maladies Infectieuses, CHU de Caen
Caen, 14033, France
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
Lyon, 69317, France
CHU Gui de Chauliac, Maladies Infectieuses Dpt
Montpellier, 34295, France
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, 44093, France
Centre Hospitalier Universitaire de Nice
Nice, 06200, France
Department of Infectious Diseases, Saint-Louis hospital
Paris, 75010, France
Hopital Saint Antoine, Service De Maladies Infectieuses
Paris, 75012, France
Bichat Hospital
Paris, 75018, France
Tenon Hospital, UPMC
Paris, 75020, France
Hopital Pitie-Salpetriere
Paris, 75651, France
Centre Hospitalier de Tourcoing
Tourcoing, 59208, France
University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
Bonn, 53127, Germany
University of Cologne, Department of Internal Medicine
Cologne, 50937, Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, 40237, Germany
Infektio Research GmbH / Infektiologikum Frankfurt
Frankfurt am Main, 60311, Germany
Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
Frankfurt am Main, 60590, Germany
ICH Study Center Hamburg
Hamburg, 20146, Germany
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, 20246, Germany
MUC Research GmbH
München, 80335, Germany
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20127, Italy
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
Rome, 00149, Italy
Dipartimento di Malattie Infettive
Torino, 10149, Italy
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Onze lieve vrouw gasthuis
Amsterdam, Netherlands
Erasmus MC, Internal Medicine, Section of Infectious Diseases
Rotterdam, 3000 CA, Netherlands
Serviço de Doenças Infecciosas, Hospital de São João
Porto, 4202-451, Portugal
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Venhälsan, Södersjukhuset
Stockholm, 11883, Sweden
CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 1ES, United Kingdom
North Manchester General Hospital
Manchester, Lancashire, M8 5RB, United Kingdom
Barts and the London NHS Trust
London, E1 1BB, United Kingdom
Homerton University Hospital
London, E9 6SR, United Kingdom
Chelsea and Westminster Hospital Foundation Trust
London, SW10 9NH, United Kingdom
St. Mary's Hospital, London (Imperial College, London)
London, W2 1NY, United Kingdom
Related Publications (3)
DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.
PMID: 22748590RESULTRockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.
PMID: 23337366RESULTClumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus 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):e121-4. doi: 10.1097/QAI.0000000000000089. No abstract available.
PMID: 24346640RESULT
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
Marshall Fordyce, 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
April 14, 2010
First Posted
April 20, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2014
Last Updated
November 11, 2015
Results First Posted
October 22, 2012
Record last verified: 2015-10