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Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E/C/F/TAF
E/C/F/TDF
E/C/F/TDF Placebo
E/C/F/TAF 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, Treatment Naive, HIV 1 Infected, Female, Women

Eligibility Criteria

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

Key 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 ≥ 1,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range

Key Exclusion Criteria:

  • A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with 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
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • The University of Alabama at Birmingham
  • Spectrum Medical Group
  • Kaiser Permanente Los Angeles
  • University of California, Los Angeles
  • Peter J. Ruane, MD, Inc.
  • Anthony Mills MD Inc
  • East Bay AIDS Center
  • Kaiser Permanente - Sacramento
  • La Playa Medical Group and Clinical Research
  • University of California, San Diego
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Apex Research, LLC
  • Yale University School of Medicine
  • Dupont Circle Physicians Group, P.C.
  • Whitman Walker Clinic
  • Capital Medical Associates, P.C.
  • Gary Richmond, MD, PA, Inc.
  • Midway Immunology & Research Center, LLC
  • AIDS Healthcare Foundation
  • The Kinder Medical Group
  • Orlando Immunology Center
  • IDOCF/ValuHealthMD, LLC
  • Infectious Diseases Associates
  • The University of South Florida
  • Infectious Disease Research Institute Inc.
  • St. Joseph's Comprenhensive Research Inisitute
  • AIDS Research and Treatment Center of the Treasure Coast
  • AIDS Research Consortium of Atlanta
  • Emory University
  • Atlanta ID Group, PC
  • Infectious Disease Specialist of Atlanta
  • Mercer University School of Medicine
  • University of Hawaii - Hawaii Center for AIDS
  • Northwestern University
  • Ruth M. Rothstein CORE Center
  • Howard Brown Health Center
  • Institute of Human Virology, University of Maryland
  • Community Research Initative
  • Brigham & Women's Hospital
  • Metrowest Medical Center
  • Baystate Infectious Diseases Clinical Research
  • Be Well Medical Center
  • Henry Ford Hospital
  • Hennepin County Medical Center
  • Central West Clinical Research, Inc.
  • Southampton Healthcare, Inc.
  • ID Care
  • Saint Michael's Medical Center
  • Southwest C.A.R.E. Center
  • Albany Medical College
  • Upstate Infectious Diseases Associates
  • Jacobi Medical Center
  • Montefiore Medical Center
  • New York Hospital Queens
  • North Shore University Hospital - Division of Infectious Diseases
  • Mount Sinai School of Medicine
  • University of North Carolina
  • Infectious Disease Consultants, PA
  • Duke University
  • Rosedale Infectious Diseases
  • Summa Health Care Center
  • University of Pennsylvania
  • Thomas Jefferson University
  • The Miriam Hospital
  • Medical University of South Carolina
  • University of South Carolina School of Medicine
  • Central Texas Clinical Research
  • St. Hope Foundation, Inc.
  • Trinity Health and Wellness Center/AIDS Arms, Inc.
  • North Texas Infectious Diseases Consultants
  • Tarrant County Infectious Disease Associates
  • Garcias' Family Health Group
  • Therapeutic Concepts, PA
  • Gordon E. Crofoot, MD, PA
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
  • Peter Shalit, MD
  • Medical College of Wisconsin
  • Holdsworth House Medical Practice
  • Taylor Square Private Clinic
  • East Sydney Doctors
  • Albion Street Centre
  • Melbourne Sexual Health Clinic
  • DIAID, Department of Dermatology, Medical University Vienna
  • Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
  • Hôpital Erasme-ULB
  • CHU Saint-Pierre University Hospital
  • Spectrum Health
  • Health Sciences Centre Winnipeg
  • The Ottawa Hospital
  • Maple Leaf Research
  • Clinique Medicale Du Quartier Latin
  • Clinique medicale l'Actuel
  • Clinique OPUS
  • Sunnybrook Health Science Center
  • Ospedale San Raffaele
  • National Center for Global Health and Medicine AIDS Clinical Center
  • HOPE Clinical Research
  • Hospital Germans Trias i Pujol
  • Hospital del Mar
  • Hospital Universitari Vall D'Hebron
  • Hospital Clinic i Provincial
  • University Hospital Bellvitge
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Complejo Hospitalario Universitario de Santiago (CHUS)
  • Universitätsspital Bern
  • Centre Hospitalier Universitaire Vaudois
  • University Hospital, Zurich
  • The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
  • Ramathibodi Hospital, Mahidol University
  • Siriraj Hospital
  • Chiang Mai University
  • Khon Kaen University
  • Bamrasnaradura Infectious Diseases Institute
  • Chelsea & Westminster Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

E/C/F/TAF (Double-Blind Phase)

E/C/F/TDF (Double-Blind Phase)

Open-Label Extension Phase

Arm Description

E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks

E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks

After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.

Outcomes

Primary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change From Baseline in CD4+ Cell Count at Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Change From Baseline in CD4+ Cell Count at Week 144
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Percent Change From Baseline in Hip BMD at Week 96
Hip BMD was assessed by DXA scan.
Percent Change From Baseline in Hip BMD at Week 144
Hip BMD was assessed by DXA scan.
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan.
Percent Change From Baseline in Spine BMD at Week 96
Spine BMD was assessed by DXA scan.
Percent Change From Baseline in Spine BMD at Week 144
Spine BMD was assessed by DXA scan.
Change From Baseline in Serum Creatinine at Week 48
Change From Baseline in Serum Creatinine at Week 96
Change From Baseline in Serum Creatinine at Week 144
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.

Full Information

First Posted
January 16, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01780506
Brief Title
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
Official Title
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 26, 2012 (Actual)
Primary Completion Date
August 26, 2014 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, 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, Treatment Naive, HIV 1 Infected, Female, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
872 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E/C/F/TAF (Double-Blind Phase)
Arm Type
Experimental
Arm Description
E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks
Arm Title
E/C/F/TDF (Double-Blind Phase)
Arm Type
Active Comparator
Arm Description
E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks
Arm Title
Open-Label Extension Phase
Arm Type
Experimental
Arm Description
After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.
Intervention Type
Drug
Intervention Name(s)
E/C/F/TAF
Other Intervention Name(s)
Genvoya®
Intervention Description
150/150/200/10 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
E/C/F/TDF
Other Intervention Name(s)
Stribild®
Intervention Description
150/150/200/300 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
E/C/F/TDF Placebo
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
E/C/F/TAF Placebo
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Description
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144
Description
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Weeks 96 and 144
Title
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
Description
The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Weeks 48, 96. and 144
Title
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame
Baseline; Week 48
Title
Change From Baseline in CD4+ Cell Count at Week 96
Time Frame
Baseline; Week 96
Title
Change From Baseline in CD4+ Cell Count at Week 144
Time Frame
Baseline; Week 144
Title
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Description
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in Hip BMD at Week 96
Description
Hip BMD was assessed by DXA scan.
Time Frame
Baseline; Week 96
Title
Percent Change From Baseline in Hip BMD at Week 144
Description
Hip BMD was assessed by DXA scan.
Time Frame
Baseline; Week 144
Title
Percent Change From Baseline in Spine BMD at Week 48
Description
Spine BMD was assessed by DXA scan.
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in Spine BMD at Week 96
Description
Spine BMD was assessed by DXA scan.
Time Frame
Baseline; Week 96
Title
Percent Change From Baseline in Spine BMD at Week 144
Description
Spine BMD was assessed by DXA scan.
Time Frame
Baseline; Week 144
Title
Change From Baseline in Serum Creatinine at Week 48
Time Frame
Baseline; Week 48
Title
Change From Baseline in Serum Creatinine at Week 96
Time Frame
Baseline; Week 96
Title
Change From Baseline in Serum Creatinine at Week 144
Time Frame
Baseline; Week 144
Title
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48
Description
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time Frame
Up to 48 weeks
Title
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96
Description
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time Frame
Up to 96 weeks
Title
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
Description
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time Frame
Up to 144 weeks
Title
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
Description
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
Description
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 96
Title
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144
Description
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 144
Title
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
Description
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
Description
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 96
Title
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144
Description
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame
Baseline; Week 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 ≥ 1,000 copies/mL at screening No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF) Normal electrocardiogram (ECG) Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin Adequate hematologic function Serum amylase ≤ 5 × ULN Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range Key Exclusion Criteria: A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening Hepatitis B surface antigen (HBsAg) positive Hepatitis C antibody positive Individuals experiencing decompensated cirrhosis Females who are breastfeeding Positive serum pregnancy test Have an implanted defibrillator or pacemaker Current alcohol or substance use judged by the Investigator to potentially interfere with 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 Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements Participation in any other clinical trial (including observational trials) without prior approval Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
The 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
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California, Los Angeles
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
Anthony Mills MD Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
East Bay AIDS Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Kaiser Permanente - Sacramento
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
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Apex Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Dupont Circle Physicians Group, P.C.
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, P.C.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Gary Richmond, MD, PA, Inc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Midway Immunology & Research Center, LLC
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
AIDS Healthcare Foundation
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/ValuHealthMD, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Infectious Diseases Associates
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
The University of South Florida
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 Comprenhensive Research Inisitute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research and Treatment Center of the Treasure Coast
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 Specialist 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
31201
Country
United States
Facility Name
University of Hawaii - Hawaii Center for AIDS
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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
Institute of Human Virology, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Community Research Initative
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Metrowest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
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 Hospital
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, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Southampton Healthcare, Inc.
City
Saint 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 Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Southwest C.A.R.E. Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Upstate Infectious Diseases Associates
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
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 - Division of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Infectious Disease Consultants, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22710
Country
United States
Facility Name
Rosedale Infectious Diseases
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Summa Health Care Center
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
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Hope Foundation, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
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
North Texas Infectious Diseases Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
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
Garcias' Family Health Group
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
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
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, LLC (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
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Darlington
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 NSW
Country
Australia
Facility Name
Albion Street Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Melbourne Sexual Health Clinic
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
DIAID, Department of Dermatology, Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Hôpital Erasme-ULB
City
Anderlecht
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Saint-Pierre University Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Spectrum Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2T1
Country
Canada
Facility Name
Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Maple Leaf Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Facility Name
Clinique Medicale Du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Clinique OPUS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1T1
Country
Canada
Facility Name
Sunnybrook Health Science Center
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
National Center for Global Health and Medicine AIDS Clinical Center
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
HOPE Clinical Research
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Hospital Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS)
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Universitätsspital Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
University Hospital, Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
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
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Diseases Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Chelsea & Westminster Hospital
City
London
ZIP/Postal Code
SW10 9TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
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Citation
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Results Reference
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PubMed Identifier
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Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.
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Citation
Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.
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Citation
Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.
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Citation
Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.
Results Reference
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PubMed Identifier
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Citation
Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.
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Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.
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Learn more about this trial

Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

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