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Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF 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, Women, Female

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 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
  • Age ≥ 18 years

Key Exclusion Criteria:

  • A new 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
  • Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF

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

Sites / Locations

  • University of Alabama at Birmingham
  • Spectrum Medical Group
  • Kaiser Permanente - Los Angeles Medical Center
  • University of Southern California AIDS Clinical Trials Group
  • Peter J. Ruane, Inc.
  • Anthony Mills MD Inc
  • Alameda County Medical Center
  • Stanford University
  • University of California, Davis Medical Center
  • Kaiser Permanente Medical Group
  • La Playa Medical Group and Clinical Research
  • Kaiser Permanente San Francisco
  • Kaiser Permanente
  • Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center
  • University of Colorado
  • APEX Research LLC
  • Greenwich Hospital
  • Yale University
  • Dupont Circle Physicians Group
  • Whitman-Walker Health
  • Capital Medical Associates, PC
  • Medical Faculty Associates
  • Gary J. Richmond,M.D.,P.A.
  • Midway Immunology and Research Center
  • AIDS Healthcare Foundation
  • AIDS Healthcare Foundation
  • Orlando Immunology Center
  • Idocf/Valuhealthmd
  • Infectious Diseases Associates of NW FL
  • University of South Florida
  • Infectious Disease Research Institute Inc.
  • St. Joseph's Comprehensive Research Institute
  • Triple O Research Institute PA
  • AIDS Research Consortium of Atlanta
  • Atlanta ID Group, PC
  • Emory University
  • Georgia Regents University
  • Infectious Disease Specialist of Atlanta
  • Mercer University
  • University of Hawaii - Hawaii Center for AIDS
  • Rush University Medical Center, Section of Infectious Diseases
  • The Ruth M. Rothstein CORE Center
  • Community Research Initiative of New England
  • The Research Institute
  • Be Well Medical Center
  • Henry Ford Health System
  • Hennepin County Medical Center
  • Central West Clinical Research
  • Southampton Healthcare, Inc.
  • ID Care
  • Southwest CARE Center
  • Albany Medical College
  • Upstate ID Assoc
  • Jacobi Medical Center
  • Montefiore Medical Center
  • North Shore University Hospital - Division of Infectious Diseases
  • Chelsea Village Medical
  • Columbia University Medical Center
  • Weill Cornell Medical College
  • University of North Carolina AIDS Clinical Trials Unit
  • Carolinas Medical Center Myer's Park Clinic
  • Duke University Medical Center
  • East Carolina University The Brody School of Medicine
  • Rosedale Infectious Disseases
  • Wake Forest University Health Sciences
  • University of Pennsylvania
  • The Miriam Hospital
  • Central Texas Clinical Research
  • St. Hope Foundation, Inc.
  • Trinity Health & Wellness Center / AIDS Arms, Inc.
  • Southwest Infectious Disease Clinical Research, Inc.
  • North Texas Infectious Diseases Consultants
  • Tarrant County Infectious Disease Associates
  • 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, MD
  • Research Institute of McGill University Health Care
  • Clinique Medicale L'actuel
  • University Health Network/Toronto General Hospital
  • Maple Leaf Research
  • Spectrum Health Care
  • Instituto Dominicano de Estudios Virologicos--IDEV
  • Hopital de la Croix Rousse
  • University Hospital of Montpellier (CHU-Gui de Chauliac)
  • Archet 1 CHU de Nice, Department of Infectiology
  • Saint Louis Hospital of Infectious Diseases
  • Hopital Saint Antoine
  • Hôpital Bichat Claude Bernard
  • Hopital Tenon
  • Hopital Pitie Salpetriere
  • CH Tourcoing
  • Universitaria di Bologna-Policlicnico S' Orsola Malpighi
  • IRCCS Ospedale San Raffaele
  • Hospital Civil de Guadalajara
  • Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"
  • Onze Lieve Vrouwe Gasthuis
  • Serviço de Doenças Infecciosas, HUC-CHUC, EPE
  • Hospital Santo Antonio dos Capuchos
  • Hospital de Santa Maria - CHLN, EPE
  • Centro Hospitalar do Porto - Hospital Joaquim Urbano
  • Hope Clinical Research
  • University of Puerto Rico ACTU
  • Venhalsan / Sodersjukhuset
  • Karolinska University Hospital, Huddinge
  • Whittall Street Clinic
  • Heart Of England NHS Foundation Trust
  • Brighton and Sussex University Hospitals NHS Trust
  • Brownlee Centre, Gartnavel General Hospital
  • Barts Health NHS Trust
  • Royal Free London NHS Foundation Trust
  • Kings College Hospital
  • Chelsea and Westminster
  • Mortimer Market Centre
  • North Manchester General 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)

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

Open-Label E/C/F/TAF

Arm Description

E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.

E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.

After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving 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 Week 96
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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.
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 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.
Change From Baseline in CD4+ Cell Count at Week 48
Change From Baseline in CD4+ Cell Count at Week 96
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 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.
Change From Baseline in Serum Creatinine at Week 48
Change From Baseline in Serum Creatinine at Week 96
Percentage of Participants With 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 With 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.
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 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.

Full Information

First Posted
February 20, 2013
Last Updated
February 18, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01797445
Brief Title
Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF 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
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2013 (Actual)
Primary Completion Date
September 19, 2014 (Actual)
Study Completion Date
October 3, 2018 (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) 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, Women, Female

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)
Arm Type
Experimental
Arm Description
E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
Arm Title
E/C/F/TDF (Double-Blind)
Arm Type
Active Comparator
Arm Description
E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
Arm Title
Open-Label E/C/F/TAF
Arm Type
Experimental
Arm Description
After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates 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 Achieving 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 Week 96
Description
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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 96
Title
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
Description
The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 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
Weeks 48 and 96
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
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 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
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
Percentage of Participants With 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
Baseline to Week 48
Title
Percentage of Participants With 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
Baseline to Week 96
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 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

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 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 Age ≥ 18 years Key Exclusion Criteria: A new 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 Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF 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
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 Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of Southern California AIDS Clinical Trials Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Peter J. Ruane, 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
Alameda County Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
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
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Kaiser Permanente
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90275
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
APEX Research LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Greenwich Hospital
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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 Health
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
Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
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
34952
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
AIDS Healthcare Foundation
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
City
Orlando
State/Province
Florida
ZIP/Postal Code
32836
Country
United States
Facility Name
Infectious Diseases Associates of NW FL
City
Sarasota
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
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 Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Triple O Research Institute PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
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
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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
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
96821
Country
United States
Facility Name
Rush University Medical Center, Section of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
The Ruth M. Rothstein CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
The Research Institute
City
West Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072-3436
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
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
Southwest CARE 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 ID Assoc
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
North Shore University Hospital - Division of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Chelsea Village Medical
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina AIDS Clinical Trials Unit
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center Myer's Park Clinic
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 The Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Rosedale Infectious Disseases
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
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
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 & Wellness Center / AIDS Arms, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75215
Country
United States
Facility Name
Southwest Infectious Disease Clinical Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
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
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, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Institute of McGill University Health Care
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Clinique Medicale L'actuel
City
Montreal
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
University Health Network/Toronto General Hospital
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Maple Leaf Research
City
Toronto
ZIP/Postal Code
M5G 1K2
Country
Canada
Facility Name
Spectrum Health Care
City
Vancouver
ZIP/Postal Code
V6Z 2T1
Country
Canada
Facility Name
Instituto Dominicano de Estudios Virologicos--IDEV
City
Santo Domingo
ZIP/Postal Code
99999
Country
Dominican Republic
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
University Hospital of Montpellier (CHU-Gui de Chauliac)
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Archet 1 CHU de Nice, Department of Infectiology
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Saint Louis Hospital of Infectious Diseases
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CH Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Universitaria di Bologna-Policlicnico S' Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Hospital Civil de Guadalajara
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Serviço de Doenças Infecciosas, HUC-CHUC, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Santo Antonio dos Capuchos
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Hospital de Santa Maria - CHLN, EPE
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital Joaquim Urbano
City
Porto
ZIP/Postal Code
4369-004
Country
Portugal
Facility Name
Hope Clinical Research
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
University of Puerto Rico ACTU
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Venhalsan / Sodersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Whittall Street Clinic
City
Birmingham
ZIP/Postal Code
B4 6DH
Country
United Kingdom
Facility Name
Heart Of England NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Brownlee Centre, Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E11BB
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RJ
Country
United Kingdom
Facility Name
Chelsea and Westminster
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Mortimer Market Centre
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
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 www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
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Citation
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Results Reference
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Citation
Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.
Results Reference
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PubMed Identifier
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Citation
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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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
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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 Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

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