search
Back to results

Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla 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
Atripla
Stribild Placebo
Atripla 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 Treatment Naive, HIV 1 Infected

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
  • 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

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, 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

Sites / Locations

  • University of Alabama at Birmingham
  • Spectrum Medical Group
  • Health for Life Clinic PLLC
  • AHF Research Center
  • Kaiser Permanente Hospital
  • Living Hope Clinical Foundation
  • Kaiser Permanente
  • Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
  • UCLA Center for Clinical Aids Research and Education
  • 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
  • Kaiser Permanente Medical Group
  • La Playa Medical Group and Clinical Research
  • San Francisco General Hospital, University of California, San Francisco
  • Metropolis Medical
  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • Apex Research, LLC
  • 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, MD, PA
  • Midway Immunology and Research Center
  • Wohlfeiler, Piperato and Associates, LLC
  • The Kinder Medical Group
  • University of Miami School of Medicine
  • Orlando Immunology Center
  • Idocf/ Valuhealthmd, 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
  • Emory University
  • Atlanta ID Group, PC
  • Infectious Disease Specialists of Atlanta
  • Mercer University School of Medicine
  • Leahi Hospital
  • Ruth M. Rothstein CORE Center
  • Howard Brown Health Center
  • Johns Hopkins University School of Medicine
  • Brigham & Women's Hospital
  • Community Research Initiative
  • The Research Institute
  • Baystate Infectious Diseases Clinical Research
  • Be Well Medical Center
  • Henry Ford Health System
  • Hennepin County Medical Center
  • Central West Clinical Research
  • Southampton Healthcare
  • ID Care
  • Saint Michaels Medical Center
  • South Jersey Infectious Disease
  • Garden State Infectious Diseases Associates, PA
  • SouthWest CARE Center
  • Upstate ID Association
  • Montefiore Medical Center - AIDS Center
  • Jacobi Medical Center
  • SUNY Downstate Medical Center
  • New York Hospital Queens
  • North Shore University Hospital
  • Greiger Clinic
  • Beth Israel Medical Center
  • Chelsea Village Medical, PC
  • Ricky K. Hsu, MD, PC
  • The Aaron Diamond AIDS Research Center
  • Clinical and Translational Research Center
  • Carolinas Medical Center-Myers Park
  • Duke University Medical Center
  • East Carolina University
  • Rosedale Infectious Diseases
  • Wake Forest University Health Sciences
  • Summa Health System
  • University of Pennsylvania
  • Philadelphia FIGHT
  • University of South Carolina
  • Southwest Infectious Disease Clinical Research, Inc.
  • Peabody Health Center
  • Tarrant County Infectious Disease Associates
  • Valley AIDS Council
  • Therapeutic Concepts
  • Gordon E. Crofoot MD PA
  • Research Access Network
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
  • Peter Shalit, MD
  • Rockwood Pulmonary and Critical Care
  • Medical College of Wisconsin
  • Instituto de Investigacion Clentifica del Sur
  • Clinical Research Puerto Rico
  • HOPE Clinical Research
  • VA Caribbean Healthcare System
  • University of Puerto Rico, School of Medicine, Proyecto ACTU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stribild

Atripla

Arm Description

Stribild plus placebo to match Atripla

Atripla plus placebo to match Stribild

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
March 17, 2010
Last Updated
October 15, 2015
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01095796
Brief Title
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla 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 Efavirenz/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
March 2010 (undefined)
Primary Completion Date
August 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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stribild
Arm Type
Experimental
Arm Description
Stribild plus placebo to match Atripla
Arm Title
Atripla
Arm Type
Active Comparator
Arm Description
Atripla plus placebo to match Stribild
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)
Atripla
Intervention Description
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime
Intervention Type
Drug
Intervention Name(s)
Stribild Placebo
Intervention Description
Placebo to match Stribild STR administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Atripla Placebo
Intervention Description
Placebo to match Atripla tablet administered orally once daily prior to bedtime
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 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 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Rhee, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
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
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
UCLA Center for Clinical Aids Research and Education
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
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
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
San Francisco General Hospital, University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Metropolis 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
Apex Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
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, MD, PA
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
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Idocf/ Valuhealthmd, 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
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta ID Group, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
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
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Community Research Initiative
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Central West Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
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
SouthWest CARE Center
City
Sante Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Upstate ID Association
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center - AIDS Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
31210
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York Hospital Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
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
Ricky K. Hsu, MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
The Aaron Diamond AIDS Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Clinical and Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
Southwest Infectious Disease Clinical Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Peabody Health Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75215
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
Valley AIDS Council
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Therapeutic Concepts
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, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Rockwood Pulmonary and Critical Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto de Investigacion Clentifica del Sur
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
HOPE Clinical Research
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
University of Puerto Rico, School of Medicine, Proyecto ACTU
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22748591
Citation
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. Erratum In: Lancet. 2012 Aug 25;380(9843):730.
Results Reference
result
PubMed Identifier
23392460
Citation
Zolopa 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.
Results Reference
result
PubMed Identifier
24256630
Citation
Wohl 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.
Results Reference
result

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

We'll reach out to this number within 24 hrs