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

• ClinicalTrials.gov Identifier: NCT01815736
• Recruitment Status: Completed
• First Posted: March 21, 2013
• Results First Posted: April 14, 2016
• Last Update Posted: April 13, 2021
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

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.

Condition or disease	Intervention/treatment	Phase
HIV; HIV Infections	Drug: E/C/F/TAF; Drug: E/C/F/TDF; Drug: EFV/FTC/TDF; Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 27, 2013
• Actual Primary Completion Date: March 16, 2015
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: E/C/F/TAF; 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.	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily; Other Name: EVG/COBI/FTC/TAF; Genvoya®
Active Comparator: Stay on Baseline Treatment Regimen (SBR); 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.	Drug: E/C/F/TDF; 150/150/200/300 mg FDC tablet administered orally once daily; Other Name: Stribild®; Drug: EFV/FTC/TDF; 600/200/300 mg FDC tablet administered orally once daily; Other Name: Atripla®; Drug: RTV; 100 mg tablet administered orally once daily; Other Name: Norvir®; Drug: ATV; 300 mg capsule administered orally once daily; Other Name: Reyataz®; Drug: FTC/TDF; 200/300 mg tablet administered orally once daily; Other Name: Truvada®; Drug: COBI; 150 mg tablet administered orally once daily; Other Names: Tybost®; GS-9350

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: 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 :

1. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; 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.
2. Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
   Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
3. Change From Baseline in Serum Creatinine at Week 48 [ Time Frame: Baseline; Week 48 ]
4. Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 [ Time Frame: Baseline; 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.

5. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: 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.
6. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 [ Time Frame: 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.
7. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 [ Time Frame: 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.
8. Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline; 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.
9. Change From Baseline in CD4 Cell Count at Weeks 96 [ Time Frame: Baseline; Week 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Arizona

Southwest Center for HIV/AIDS

Phoenix, Arizona, United States, 85006

Spectrum Medical Group

Phoenix, Arizona, United States, 85012

United States, Arkansas

Health for Life Clinic PLLC

Little Rock, Arkansas, United States, 72207

United States, California

AHF Research Center

Beverly Hills, California, United States, 90211

Michael Keith Wensley, MD, Inc., A Medical Corporation

Costa Mesa, California, United States, 92626

Living Hope Clinical Foundation

Long Beach, California, United States, 90813

Kaiser Permanente

Los Angeles, California, United States, 90027

Jeffrey Goodman Special Care Clinic

Los Angeles, California, United States, 90028

Peter J Ruane, MD, Inc

Los Angeles, California, United States, 90036

Anthony Mills MD Inc

Los Angeles, California, United States, 90069

Orange Coast Medical Group

Newport Beach, California, United States, 92663

Alameda County Medical Center

Oakland, California, United States, 94602

East Bay AIDS Center

Oakland, California, United States, 94609

Stanford University

Palo Alto, California, United States, 94303

University of California, Davis Medical Center

Sacramento, California, United States, 95817

Kaiser Permanente Medical Group

Sacramento, California, United States, 95825

La Playa Medical Group and Clinical Research

San Diego, California, United States, 92103

Metropolis Medical Group

San Francisco, California, United States, 94109

Kaiser Permanente Medical Center, Clinical Trials Unit

San Francisco, California, United States, 94118

Kaiser Permanente Hospital

San Leandro, California, United States, 94577

United States, Colorado

Apex Research LLC

Denver, Colorado, United States, 80209

United States, Connecticut

Greenwich Hospital

Greenwich, Connecticut, United States, 06830

Yale University HIV Clinical Trials Program

New Haven, Connecticut, United States, 06510

United States, District of Columbia

Dupont Circle Physicians Group

Washington, District of Columbia, United States, 20009

Whitman Walker Clinic

Washington, District of Columbia, United States, 20009

Capital Medical Associates, PC

Washington, District of Columbia, United States, 20036

George Washington University Medical Faculty Associates

Washington, District of Columbia, United States, 20037

United States, Florida

Therafirst Medical Center

Fort Lauderdale, Florida, United States, 33308

Broward Health/Comprehensive Care Center

Fort Lauderdale, Florida, United States, 33311

Gary J. Richmond,M.D.,P.A.

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Wohlfeiler, Piperato and Associates, LLC

Miami Beach, Florida, United States, 33139

The Kinder Medical Group

Miami, Florida, United States, 33133

Orlando Immunology Center

Orlando, Florida, United States, 32803

IDOCF/ Value Health MD, LLC

Orlando, Florida, United States, 32806

University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

Tampa, Florida, United States, 33602

Infectious Disease Research Institute Inc.

Tampa, Florida, United States, 33614

St. Joseph's Comprehensive Research Institute

Tampa, Florida, United States, 33615

United States, Georgia

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

Atlanta ID Group, PC

Atlanta, Georgia, United States, 30309

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Mercer University School of Medicine

Macon, Georgia, United States, 31201

United States, Hawaii

University of Hawaii - Hawaii Center for AIDS

Honolulu, Hawaii, United States, 96816

United States, Illinois

Ruth M. Rothstein CORE Center

Chicago, Illinois, United States, 60612

Howard Brown Health Center

Chicago, Illinois, United States, 60613

NorthStar Medical Center

Chicago, Illinois, United States, 60657

United States, Massachusetts

Community Research Initiative of New England

Boston, Massachusetts, United States, 02111

The Research Institute

Springfield, Massachusetts, United States, 01105

Baystate Infectious Diseases Clinical Research

Springfield, Massachusetts, United States, 01199

United States, Michigan

Be Well Medical Center

Berkley, Michigan, United States, 48072

Henry Ford Health System

Detroit, Michigan, United States, 48202

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

United States, Missouri

Central West Clinical Research

Saint Louis, Missouri, United States, 63108

Saint Louis University

Saint Louis, Missouri, United States, 63110

Southampton Healthcare

Saint Louis, Missouri, United States, 63139

United States, New Jersey

ID Care

Hillsborough, New Jersey, United States, 08844

Saint Michaels Medical Center

Newark, New Jersey, United States, 07102

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

United States, New Mexico

SouthWest CARE Center

Santa Fe, New Mexico, United States, 87505

United States, New York

Upstate ID Association

Albany, New York, United States, 12208

Albany Medical College

Albany, New York, United States, 12209

Jacobi Medical Center

Bronx, New York, United States, 10461

Montefiore Medical Center - AIDS Center

Bronx, New York, United States, 10467

New York Hospital Queens

Flushing, New York, United States, 11355

North Shore University Hospital, Divison of Infectious Diseases

Manhasset, New York, United States, 11030

Greiger Clinic

Mount Vernon, New York, United States, 10550

Beth Israel Medical Center- Division of Infectious Diseases

New York, New York, United States, 10003

Chelsea Village Medical, PC

New York, New York, United States, 10011

Ricky K. Hsu, MD

New York, New York, United States, 10011

United States, North Carolina

University of NC AIDS Clinical Trials Unit

Chapel Hill, North Carolina, United States, 27599

Carolinas Medical Center-Myers Park

Charlotte, North Carolina, United States, 28207

Duke University Health System

Durham, North Carolina, United States, 27710

East Carolina University

Greenville, North Carolina, United States, 27834

Rosedale Infectious Diseases

Huntersville, North Carolina, United States, 28078

United States, Ohio

Summa Health System

Akron, Ohio, United States, 44304

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Palmetto Health Richland

Columbia, South Carolina, United States, 29203

United States, Texas

AIDS Arms, Inc./ Peabody Health Center

Dallas, Texas, United States, 75215

Southwest Infectious Disease Clinical Research, Inc.

Dallas, Texas, United States, 75219

Tarrant County Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Garcia's Family Health Group

Harlingen, Texas, United States, 78550

Therapeutic Concepts, P.A.

Houston, Texas, United States, 77004

Gordon E. Crofoot MD PA

Houston, Texas, United States, 77098

Research Access Network

Houston, Texas, United States, 77098

DCOL Center for Clinical Research

Longview, Texas, United States, 75605

United States, Virginia

Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

Annandale, Virginia, United States, 22003

United States, Washington

Peter Shalit, M.D.

Seattle, Washington, United States, 98104

Premier Clinical Research

Spokane, Washington, United States, 99202

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

East Sydney Doctors

Darlinghurst, New South Wales, Australia, 2010

Holdsworth House Medical practice

Darlinghurst, New South Wales, Australia, 2010

St Vincent's Hospital, Sydney

Darlinghurst, New South Wales, Australia, 2010

Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia, 2010

Albion Street Centre

Surry Hills, New South Wales, Australia, 2010

Australia, Victoria

Melbourne Sexual Health Clinic

Carlton, Victoria, Australia, 3053

Alfred Hospital

Melbourne, Victoria, Australia, 3004

Northside Clinic

Melbourne, Victoria, Australia, 3068

Prahran Market Clinic

South Yarra, Victoria, Australia, 3141

Austria

Medizinische Universität Graz

Graz, Austria, 8020

Medizinische Universitat Wien

Vienna, Austria, 1090

SMZ Baumgartner Hoehe - Otto-Wagner-Spital

Vienna, Austria, 1140

Belgium

CHU Saint-Pierre University Hospital

Brussels, Belgium, 1000

Hôpital Universitaire Erasme - ULB

Ghent, Belgium, 1070

Brazil

Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz

Rio de Janeiro, Brazil, 21040-360

Faculdade de Medicina do ABC

Santo Andre, Brazil, 09060-650

São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas

Sao Paulo, Brazil, 01246-900

São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS

Sao Paulo, Brazil, 04121-000

Canada, British Columbia

Ubc Downtown I.D. Clinic

Vancouver, British Columbia, Canada, V6Z 2C7

Canada, Manitoba

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada, R3A 1R9

Canada, Ontario

Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Maple Leaf Research

Toronto, Ontario, Canada, M5G 1K2

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada, M5G 2N2

Canada, Quebec

Clinique medicale l'Actuel

Montreal, Quebec, Canada, H2L 4P9

Clinique Medicale du Quartier Latin

Montreal, Quebec, Canada, H2L 5B1

Clinique OPUS

Montreal, Quebec, Canada, H3A 1T1

McGill University Health Centre (MUHC) - Montral Chest Institute

Montréal, Quebec, Canada, H2X 2P4

Denmark

Epidemiklinikken 5112, Rigshospitalet

Copenhagen, Denmark, 2100

Dominican Republic

Instituto Dominicano de Estudios Virologicos - IDEV

Santo Domingo, Dominican Republic

France

Hôpital de La Croix Rousse

Lyon, France, 75970

CHU Hotel Dieu

Nantes, France, 44093

Archet 1 CHU de Nice - 6ème Niveau

Nice, France, 06200

Hôpital Saint Louis

Paris, France, 75010

Hopital Saint Antoine

Paris, France, 75012

Bichat Hospital

Paris, France, 75018

Centre Hospitalier de Tourcoing

Tourcoing, France, 59208

Germany

EPIMED GmbH

Berlin, Germany, 12157

University of Bonn

Bonn, Germany, 53127

Center for HIV and Hepatogastroenterology

Duesseldorf, Germany, 40237

Infektio Research GmbH / Infektiologikum Frankfurt

Frankfurt am Main, Germany, 60311

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany, 60590

Universitatsklinikum Freiburg

Freiburg, Germany, 79106

ICH Study Center Hamburg

Hamburg, Germany, 20146

University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

Hamburg, Germany, 20246

University of Cologne, Department of Internal Medicine

Köln, Germany, 50937

MUC Research GmbH

München, Germany, 80335

Italy

Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

Milano, Italy, 20157

Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy, 20127

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

Rome, Italy, 00149

Comprensorio Amedeo Di Savoia Birago Di Vische

Torino, Italy, 10149

Mexico

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Netherlands

Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten

Amsterdam, Netherlands, 1091 AC

Erasmus MC

Rotterdam, Netherlands, 3000 CA

Portugal

Hospital de Santa Maria

Lisbon, Portugal, 1649-035

Servico De Doencas Infecciosas - Hospital De Sao Joao

Porto, Portugal, 4202-451

Puerto Rico

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909

HOPE Clinical Research

San Juan, Puerto Rico, 00909

VA Caribbean Healthcare System

San Juan, Puerto Rico, 00921

Spain

Hospital Universitari De Bellvitge

Barcelona, Spain, 08907

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Virgen del Rocio

Sevilla, Spain, 41013

Sweden

Södersjukhuset

Stockholm, Sweden, 11883

Switzerland

Universitätsklinik für Infektiologie, Universitätsspital Bern

Bern, Switzerland, 3010

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, 1011

University Hospital of Zurich

Zürich, Switzerland, 8091

Thailand

HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

Bangkok, Thailand, 10330

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine

Bangkok, Thailand, 10700

Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

Chiang Mai, Thailand, 50200

Khon Kaen University

Khon Kaen, Thailand, 40002

United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom, BN2 1ES

Barts and the London NHS Trust

London, United Kingdom, E1 1BB

Chelsea and Westminster Hospital Foundation Trust

London, United Kingdom, SW10 9NH

Courtyard Clinic, St. Georges Hospital

London, United Kingdom, SW17 0QT

North Manchester General Hospital

Manchester, United Kingdom, M8 5RB

Sponsors and Collaborators

Gilead Sciences

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

More Information

Publications of Results:

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.

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.

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.

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.

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.

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.

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.

Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.

Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.

Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.

Mills A, Andrade J, Di Perri G, Van Lunzen J, 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. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.

Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.

Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.

Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.

Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.

Viciana P, Mills A, Andrade J, Diperri G, 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. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.

Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, 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. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.

Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.

Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.

Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.

Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019.

Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.

Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.

Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.

Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.

Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.

Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jul 8:1-9. doi: 10.1080/15284336.2019.1589232. Online ahead of print.

Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.

Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.

Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.

Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.

DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20.

Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.

Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.

Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.

Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.

Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.

Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 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 # LB-087.

Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT01815736
• Other Study ID Numbers: GS-US-292-0109; 2012-005114-20 ( EudraCT Number )
• First Posted: March 21, 2013
• Results First Posted: April 14, 2016
• Last Update Posted: April 13, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.
• URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:

HIV; HIV 1 Infected; Virologically-Suppressed

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Anti-Retroviral Agents