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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

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Stribild
ATV
Ritonavir
FTC/TDF
Stribild Placebo
ATV Placebo
RTV Placebo
FTC/TDF Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV 1 Infection, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Spectrum Medical Group
  • Health for Life Clinic PLLC
  • AHF Research Center
  • CSI Clinical Trials, Inc.
  • Apex Research, LLC
  • Kaiser Permanente Hospital
  • Living Hope Clinical Foundation
  • Kaiser Permanente
  • Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
  • Peter J Ruane, MD, Inc
  • Cedars-Sinai Medical Center
  • Anthony Mills MD Inc
  • Orange Coast Medical Group
  • Alameda County Medical Center
  • East Bay AIDS Center
  • Stanford University
  • University of California, Davis Medical Center
  • Kaiser Permanente Medical Group
  • La Playa Medical Group and Clinical Research
  • Metropolitan Medical
  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • National Jewish Health
  • Yale University HIV Clinical Trials Program
  • The Stamford Hospital
  • Dupont Circle Physicians Group
  • Whitman Walker Clinic
  • Capital Medical Associates, PC
  • George Washington University Medical Faculty Associates
  • Therafirst Medical Center
  • Broward Health/Comprehensive Care Center
  • Gary J. Richmond,M.D., P.A.
  • Midway Immunology and Research Center
  • Wohlfeiler, Piperato and Associates, LLC
  • The Kinder Medical Group
  • Orlando Immunology Center
  • IDOCF/ ValueHealthMD, LLC
  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
  • Infectious Disease Research Institute Inc.
  • St. Joseph's Comprehensive Research Institute
  • Treasure Coast Infectious Disease Consultants
  • AIDS Research Consortium of Atlanta
  • Infectious Disease Solutions, PC
  • Mercer University School of Medicine
  • Leahi Hospital
  • Ruth M. Rothstein CORE Center
  • Howard Brown Health Center
  • The Research Institute
  • Baystate Infectious Diseases Clinical Research
  • Be Well Medical Center
  • Henry Ford Health System
  • Hennepin County Medical Center
  • CentralWest Clinical Research
  • Division of Infectious Diseases, St. Louis University Medical Center
  • Southampton Healthcare
  • ID Care
  • Saint Michaels Medical Center
  • South Jersey Infectious Disease
  • Garden State Infectious Diseases Associates, PA
  • Upstate ID Association
  • Albany Medical College
  • Montiefiore Medical Center- AIDS Center
  • STAR Health Care Center (SUNY Downstate)
  • North Shore University Hospital
  • Greiger Clinic
  • Beth Israel Medical Center
  • Chelsea Village Medical, PC
  • AIDS Care
  • Carolinas Medical Center-Myers Park
  • Duke University Medical Center
  • East Carolina University
  • Rosedale Infectious Diseases
  • Wake Forest University Health Sciences
  • Summa Health System
  • Division of Infectious Diseases, Thomas Jefferson University
  • Philadelphia FIGHT
  • University of South Carolina
  • Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)
  • Trinity Health and Wellness Center/AIDS Arms, Inc.
  • Tarrant County Infectious Disease Associates
  • Garcia's Family Health Group
  • Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)
  • Gordon E. Crofoot MD PA
  • Research Access Network
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
  • Peter Shalit, M.D.
  • Holdsworth House Medical practice
  • National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales
  • Albion Street Centre
  • East Sydney Doctors
  • Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)
  • Alfred Hospital
  • Northside Clinic
  • Taylor Square Private Clinica
  • LKH Graz West
  • Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna
  • Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
  • CHU Saint-Pierre University Hospital
  • Hôpital Universitaire Erasme - ULB
  • University of Ghent
  • Southern Alberta Clinic
  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
  • Sunnybrook Health Sciences Centre
  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
  • University Health Network, Toronto General Hospital
  • Clinique medicale l'Actuel
  • Clinique Medicale du Quartier Latin
  • Epidemiklinikken 5112, Rigshospitalet
  • Service des Maladies Infectieuses, CHU de Caen
  • Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
  • CHU Gui de Chauliac, Maladies Infectieuses Dpt
  • CHU de Nantes Hopital de l'Hotel Dieu
  • Centre Hospitalier Universitaire de Nice
  • Department of Infectious Diseases, Saint-Louis hospital
  • Hopital Saint Antoine, Service De Maladies Infectieuses
  • Bichat Hospital
  • Tenon Hospital, UPMC
  • Hopital Pitie-Salpetriere
  • Centre Hospitalier de Tourcoing
  • University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
  • Center for HIV and Hepatogastroenterology
  • Infektio Research GmbH / Infektiologikum Frankfurt
  • Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
  • ICH Study Center Hamburg
  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
  • University of Cologne, Department of Internal Medicine
  • MUC Research GmbH
  • Fondazione Centro San Raffaele del Monte Tabor
  • National Institute for Infectious Diseases "L. Spallanzani" IRCCS
  • Dipartimento di Malattie Infettive
  • Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
  • Onze lieve vrouw gasthuis
  • Erasmus MC, Internal Medicine, Section of Infectious Diseases
  • Serviço de Doenças Infecciosas, Hospital de São João
  • Clinical Research Puerto Rico
  • VA Caribbean Healthcare System
  • Venhälsan, Södersjukhuset
  • CHUV
  • Ramathibodi Hospital, Mahidol University
  • Siriraj Hospital
  • Brighton and Sussex University Hospitals NHS Trust
  • North Manchester General Hospital
  • Barts and the London NHS Trust
  • Homerton University Hospital
  • Chelsea and Westminster Hospital Foundation Trust
  • St. Mary's Hospital, London (Imperial College, London)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stribild

ATV/r + FTC/TDF

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Change = value of the relevant time point minus the baseline value
The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Full Information

First Posted
April 14, 2010
Last Updated
October 9, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01106586
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV 1 Infection, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stribild
Arm Type
Experimental
Arm Title
ATV/r + FTC/TDF
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Stribild
Intervention Description
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ATV
Intervention Description
Atazanavir 300 mg capsule administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Other Intervention Name(s)
Norvir®
Intervention Description
Ritonavir (RTV; /r) 100 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF
Other Intervention Name(s)
Truvada
Intervention Description
FTC/TDF 200/300 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Stribild Placebo
Intervention Description
Placebo to match Stribild administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ATV Placebo
Intervention Description
Placebo to match ATV administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RTV Placebo
Intervention Description
Placebo to match RTV administered orally once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF Placebo
Intervention Description
Placebo to match FTC/TDF administered orally once daily
Primary Outcome Measure Information:
Title
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
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
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
Time Frame
Week 96
Title
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
Time Frame
Week 144
Title
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
Time Frame
Week 192
Title
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
Time Frame
Week 48
Title
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Description
Change = value of the relevant time point minus the baseline value
Time Frame
Baseline; Weeks 48, 96, 144, and 192
Title
The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall Fordyce, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Spectrum Medical Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Health for Life Clinic PLLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
AHF Research Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
CSI Clinical Trials, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Apex Research, LLC
City
Denver
State/Province
California
ZIP/Postal Code
80209
Country
United States
Facility Name
Kaiser Permanente Hospital
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Living Hope Clinical Foundation
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Peter J Ruane, MD, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Anthony Mills MD Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Orange Coast Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Alameda County Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
East Bay AIDS Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
La Playa Medical Group and Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Metropolitan Medical
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Center, Clinical Trials Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University HIV Clinical Trials Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Facility Name
The Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Capital Medical Associates, PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Broward Health/Comprehensive Care Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Gary J. Richmond,M.D., P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Wohlfeiler, Piperato and Associates, LLC
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
The Kinder Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
IDOCF/ ValueHealthMD, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Infectious Disease Research Institute Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
St. Joseph's Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Infectious Disease Solutions, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Mercer University School of Medicine
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Leahi Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Ruth M. Rothstein CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Baystate Infectious Diseases Clinical Research
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
CentralWest Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Division of Infectious Diseases, St. Louis University Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Southampton Healthcare
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Saint Michaels Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Garden State Infectious Diseases Associates, PA
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Upstate ID Association
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12209
Country
United States
Facility Name
Montiefiore Medical Center- AIDS Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
STAR Health Care Center (SUNY Downstate)
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Greiger Clinic
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Chelsea Village Medical, PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
AIDS Care
City
Rochester
State/Province
New York
ZIP/Postal Code
14604
Country
United States
Facility Name
Carolinas Medical Center-Myers Park
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Rosedale Infectious Diseases
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Division of Infectious Diseases, Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Trinity Health and Wellness Center/AIDS Arms, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Tarrant County Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Garcia's Family Health Group
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Gordon E. Crofoot MD PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Research Access Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Peter Shalit, M.D.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Holdsworth House Medical practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
East Sydney Doctors
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Northside Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3068
Country
Australia
Facility Name
Taylor Square Private Clinica
City
Darlinghurst
ZIP/Postal Code
N.S.W. 2011
Country
Australia
Facility Name
LKH Graz West
City
Graz
ZIP/Postal Code
A-8010
Country
Austria
Facility Name
Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Saint-Pierre University Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Universitaire Erasme - ULB
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University of Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Southern Alberta Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R0X7
Country
Canada
Facility Name
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1L6
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Epidemiklinikken 5112, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Service des Maladies Infectieuses, CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
CHU Gui de Chauliac, Maladies Infectieuses Dpt
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nantes Hopital de l'Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Department of Infectious Diseases, Saint-Louis hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine, Service De Maladies Infectieuses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Tenon Hospital, UPMC
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Hospitalier de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Center for HIV and Hepatogastroenterology
City
Duesseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Infektio Research GmbH / Infektiologikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60311
Country
Germany
Facility Name
Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
ICH Study Center Hamburg
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University of Cologne, Department of Internal Medicine
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
MUC Research GmbH
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Dipartimento di Malattie Infettive
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Onze lieve vrouw gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus MC, Internal Medicine, Section of Infectious Diseases
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Serviço de Doenças Infecciosas, Hospital de São João
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
VA Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Venhälsan, Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Homerton University Hospital
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
St. Mary's Hospital, London (Imperial College, London)
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22748590
Citation
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.
Results Reference
result
PubMed Identifier
23337366
Citation
Rockstroh 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.
Results Reference
result
PubMed Identifier
24346640
Citation
Clumeck 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.
Results Reference
result

Learn more about this trial

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

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