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Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E/C/F/TAF
E/C/F/TDF
EFV/FTC/TDF
RTV
ATV
FTC/TDF
COBI
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, HIV 1 Infected, Virologically-Suppressed

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
  • Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study
  • Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105
  • Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening visit
  • Normal echocardiograph (ECG)
  • Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 × upper limit of the normal range (ULN)
  • Direct bilirubin ≤ 1.5 x ULN
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • 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 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens.
  • Female participants 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
  • Female participants 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 position
  • Hepatitis C antibody positive
  • Participants 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 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
  • 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 dosing requirements
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
  • Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

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

Sites / Locations

  • University of Alabama at Birmingham
  • Southwest Center for HIV/AIDS
  • Spectrum Medical Group
  • Health for Life Clinic PLLC
  • AHF Research Center
  • Michael Keith Wensley, MD, Inc., A Medical Corporation
  • Living Hope Clinical Foundation
  • Kaiser Permanente
  • Jeffrey Goodman Special Care Clinic
  • Peter J Ruane, MD, Inc
  • Anthony Mills MD Inc
  • Orange Coast Medical Group
  • Alameda County Medical Center
  • East Bay AIDS Center
  • Stanford University
  • University of California, Davis Medical Center
  • Kaiser Permanente Medical Group
  • La Playa Medical Group and Clinical Research
  • Metropolis Medical Group
  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • Kaiser Permanente Hospital
  • Apex Research LLC
  • Greenwich Hospital
  • Yale University HIV Clinical Trials Program
  • Dupont Circle Physicians Group
  • Whitman Walker Clinic
  • Capital Medical Associates, PC
  • George Washington University Medical Faculty Associates
  • Therafirst Medical Center
  • Broward Health/Comprehensive Care Center
  • Gary J. Richmond,M.D.,P.A.
  • Midway Immunology and Research Center
  • Wohlfeiler, Piperato and Associates, LLC
  • The Kinder Medical Group
  • Orlando Immunology Center
  • IDOCF/ Value Health MD, LLC
  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
  • Infectious Disease Research Institute Inc.
  • St. Joseph's Comprehensive Research Institute
  • AIDS Research Consortium of Atlanta
  • Atlanta ID Group, PC
  • Infectious Disease Specialists of Atlanta
  • Mercer University School of Medicine
  • University of Hawaii - Hawaii Center for AIDS
  • Ruth M. Rothstein CORE Center
  • Howard Brown Health Center
  • NorthStar Medical Center
  • Community Research Initiative of New England
  • The Research Institute
  • Baystate Infectious Diseases Clinical Research
  • Be Well Medical Center
  • Henry Ford Health System
  • Hennepin County Medical Center
  • Central West Clinical Research
  • Saint Louis University
  • Southampton Healthcare
  • ID Care
  • Saint Michaels Medical Center
  • South Jersey Infectious Disease
  • SouthWest CARE Center
  • Upstate ID Association
  • Albany Medical College
  • Jacobi Medical Center
  • Montefiore Medical Center - AIDS Center
  • New York Hospital Queens
  • North Shore University Hospital, Divison of Infectious Diseases
  • Greiger Clinic
  • Beth Israel Medical Center- Division of Infectious Diseases
  • Chelsea Village Medical, PC
  • Ricky K. Hsu, MD
  • University of NC AIDS Clinical Trials Unit
  • Carolinas Medical Center-Myers Park
  • Duke University Health System
  • East Carolina University
  • Rosedale Infectious Diseases
  • Summa Health System
  • University of Pennsylvania
  • Thomas Jefferson University
  • Palmetto Health Richland
  • AIDS Arms, Inc./ Peabody Health Center
  • Southwest Infectious Disease Clinical Research, Inc.
  • Tarrant County Infectious Disease Associates
  • Garcia's Family Health Group
  • Therapeutic Concepts, P.A.
  • Gordon E. Crofoot MD PA
  • Research Access Network
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
  • Peter Shalit, M.D.
  • Premier Clinical Research
  • Medical College of Wisconsin
  • East Sydney Doctors
  • Holdsworth House Medical practice
  • St Vincent's Hospital, Sydney
  • Taylor Square Private Clinic
  • Albion Street Centre
  • Melbourne Sexual Health Clinic
  • Alfred Hospital
  • Northside Clinic
  • Prahran Market Clinic
  • Medizinische Universität Graz
  • Medizinische Universitat Wien
  • SMZ Baumgartner Hoehe - Otto-Wagner-Spital
  • CHU Saint-Pierre University Hospital
  • Hôpital Universitaire Erasme - ULB
  • Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz
  • Faculdade de Medicina do ABC
  • São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas
  • São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS
  • Ubc Downtown I.D. Clinic
  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
  • Ottawa Hospital
  • Sunnybrook Health Sciences Centre
  • Maple Leaf Research
  • University Health Network, Toronto General Hospital
  • Clinique medicale l'Actuel
  • Clinique Medicale du Quartier Latin
  • Clinique OPUS
  • McGill University Health Centre (MUHC) - Montral Chest Institute
  • Epidemiklinikken 5112, Rigshospitalet
  • Instituto Dominicano de Estudios Virologicos - IDEV
  • Hôpital de La Croix Rousse
  • CHU Hotel Dieu
  • Archet 1 CHU de Nice - 6ème Niveau
  • Hôpital Saint Louis
  • Hopital Saint Antoine
  • Bichat Hospital
  • Centre Hospitalier de Tourcoing
  • EPIMED GmbH
  • University of Bonn
  • Center for HIV and Hepatogastroenterology
  • Infektio Research GmbH / Infektiologikum Frankfurt
  • Universitätsklinikum Frankfurt
  • Universitatsklinikum Freiburg
  • ICH Study Center Hamburg
  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
  • University of Cologne, Department of Internal Medicine
  • MUC Research GmbH
  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
  • Fondazione Centro San Raffaele del Monte Tabor
  • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
  • Comprensorio Amedeo Di Savoia Birago Di Vische
  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
  • Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten
  • Erasmus MC
  • Hospital de Santa Maria
  • Servico De Doencas Infecciosas - Hospital De Sao Joao
  • Clinical Research Puerto Rico
  • HOPE Clinical Research
  • VA Caribbean Healthcare System
  • Hospital Universitari De Bellvitge
  • Hospital Universitario La Paz
  • Hospital Virgen del Rocio
  • Södersjukhuset
  • Universitätsklinik für Infektiologie, Universitätsspital Bern
  • Centre Hospitalier Universitaire Vaudois
  • University Hospital of Zurich
  • HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
  • Ramathibodi Hospital, Mahidol University
  • Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine
  • Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
  • Khon Kaen University
  • Brighton and Sussex University Hospitals NHS Trust
  • Barts and the London NHS Trust
  • Chelsea and Westminster Hospital Foundation Trust
  • Courtyard Clinic, St. Georges Hospital
  • North Manchester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E/C/F/TAF

Stay on Baseline Treatment Regimen (SBR)

Arm Description

Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

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

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. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
Change From Baseline in Serum Creatinine at Week 48
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
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 Week 48
The percentage of participants achieving HIV-1 RNA < 20 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.
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
The percentage of participants achieving HIV-1 RNA < 20 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.
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Change From Baseline in CD4 Cell Count at Weeks 96
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.

Full Information

First Posted
March 19, 2013
Last Updated
March 22, 2021
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01815736
Brief Title
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Official Title
A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2013 (Actual)
Primary Completion Date
March 16, 2015 (Actual)
Study Completion Date
April 1, 2020 (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 non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV, HIV 1 Infected, Virologically-Suppressed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E/C/F/TAF
Arm Type
Experimental
Arm Description
Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.
Arm Title
Stay on Baseline Treatment Regimen (SBR)
Arm Type
Active Comparator
Arm Description
Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.
Intervention Type
Drug
Intervention Name(s)
E/C/F/TAF
Other Intervention Name(s)
EVG/COBI/FTC/TAF; 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)
EFV/FTC/TDF
Other Intervention Name(s)
Atripla®
Intervention Description
600/200/300 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
Norvir®
Intervention Description
100 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ATV
Other Intervention Name(s)
Reyataz®
Intervention Description
300 mg capsule administered orally once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
200/300 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
COBI
Other Intervention Name(s)
Tybost®, GS-9350
Intervention Description
150 mg 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
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. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in Spine BMD at Week 48
Description
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Serum Creatinine at Week 48
Time Frame
Baseline; Week 48
Title
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
Description
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Time Frame
Baseline; Week 48
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 Week 48
Description
The percentage of participants achieving HIV-1 RNA < 20 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
Title
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
Description
The percentage of participants achieving HIV-1 RNA < 20 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
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Description
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time Frame
Baseline; Week 48
Title
Change From Baseline in CD4 Cell Count at Weeks 96
Description
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
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 Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105 Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening visit Normal echocardiograph (ECG) Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 × upper limit of the normal range (ULN) Direct bilirubin ≤ 1.5 x ULN Adequate hematologic function Serum amylase ≤ 5 × ULN 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 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens. Female participants 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 Female participants 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 position Hepatitis C antibody positive Participants 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 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 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 dosing requirements Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF 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
Southwest Center for HIV/AIDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
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
Michael Keith Wensley, MD, Inc., A Medical Corporation
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
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
Jeffrey Goodman Special Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Peter J Ruane, MD, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Anthony Mills MD Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Orange Coast Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Alameda County Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
East Bay AIDS Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
La Playa Medical Group and Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Metropolis Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
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
Kaiser Permanente Hospital
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
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 HIV Clinical Trials Program
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 Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Capital Medical Associates, PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Broward Health/Comprehensive Care Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Gary J. Richmond,M.D.,P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Wohlfeiler, Piperato and Associates, LLC
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
The Kinder Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
IDOCF/ Value Health MD, 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
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
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
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
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
NorthStar Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
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
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Southampton Healthcare
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 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
SouthWest CARE Center
City
Santa 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
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12209
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 - AIDS 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, Divison of Infectious Diseases
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- Division of Infectious Diseases
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
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of NC AIDS Clinical Trials Unit
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 Health System
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
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
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
AIDS Arms, Inc./ Peabody Health Center
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
Tarrant County Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Garcia's Family Health Group
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Therapeutic Concepts, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Gordon E. Crofoot MD PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Research Access Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Peter Shalit, M.D.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Centre
City
Surry Hills
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
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Northside Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3068
Country
Australia
Facility Name
Prahran Market Clinic
City
South Yarra
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
SMZ Baumgartner Hoehe - Otto-Wagner-Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Saint-Pierre University Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Universitaire Erasme - ULB
City
Ghent
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS
City
Sao Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Ubc Downtown I.D. Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Maple Leaf Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Clinique OPUS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1T1
Country
Canada
Facility Name
McGill University Health Centre (MUHC) - Montral Chest Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Epidemiklinikken 5112, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Instituto Dominicano de Estudios Virologicos - IDEV
City
Santo Domingo
Country
Dominican Republic
Facility Name
Hôpital de La Croix Rousse
City
Lyon
ZIP/Postal Code
75970
Country
France
Facility Name
CHU Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Archet 1 CHU de Nice - 6ème Niveau
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Hospitalier de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
EPIMED GmbH
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
University of Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Center for HIV and Hepatogastroenterology
City
Duesseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Infektio Research GmbH / Infektiologikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60311
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
ICH Study Center Hamburg
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University of Cologne, Department of Internal Medicine
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
MUC Research GmbH
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Comprensorio Amedeo Di Savoia Birago Di Vische
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Servico De Doencas Infecciosas - Hospital De Sao Joao
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
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
Hospital Universitari De Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Universitätsklinik für Infektiologie, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
University Hospital of Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
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 HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
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
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Courtyard Clinic, St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
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 https://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:
PubMed Identifier
26538525
Citation
Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2.
Results Reference
result
PubMed Identifier
28259777
Citation
Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.
Results Reference
result
Citation
Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.
Results Reference
result
Citation
Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.
Results Reference
result
Citation
Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.
Results Reference
result
Citation
Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.
Results Reference
result
Citation
Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.
Results Reference
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Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

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