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
NCT ID: NCT01815736
Last Updated: 2021-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1443 participants
INTERVENTIONAL
2013-03-27
2020-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
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.
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
EFV/FTC/TDF
600/200/300 mg FDC tablet administered orally once daily
RTV
100 mg tablet administered orally once daily
ATV
300 mg capsule administered orally once daily
FTC/TDF
200/300 mg tablet administered orally once daily
COBI
150 mg tablet administered orally once daily
Interventions
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E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
EFV/FTC/TDF
600/200/300 mg FDC tablet administered orally once daily
RTV
100 mg tablet administered orally once daily
ATV
300 mg capsule administered orally once daily
FTC/TDF
200/300 mg tablet administered orally once daily
COBI
150 mg tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, United States
AHF Research Center
Beverly Hills, California, United States
Michael Keith Wensley, MD, Inc., A Medical Corporation
Costa Mesa, California, United States
Living Hope Clinical Foundation
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States
Peter J Ruane, MD, Inc
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
Alameda County Medical Center
Oakland, California, United States
East Bay AIDS Center
Oakland, California, United States
Stanford University
Palo Alto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Metropolis Medical Group
San Francisco, California, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States
Kaiser Permanente Hospital
San Leandro, California, United States
Apex Research LLC
Denver, Colorado, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Yale University HIV Clinical Trials Program
New Haven, Connecticut, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ Value Health MD, LLC
Orlando, Florida, United States
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Atlanta ID Group, PC
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Howard Brown Health Center
Chicago, Illinois, United States
NorthStar Medical Center
Chicago, Illinois, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Central West Clinical Research
St Louis, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Southampton Healthcare
St Louis, Missouri, United States
ID Care
Hillsborough, New Jersey, United States
Saint Michaels Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
SouthWest CARE Center
Santa Fe, New Mexico, United States
Upstate ID Association
Albany, New York, United States
Albany Medical College
Albany, New York, United States
New York Hospital Queens
Flushing, New York, United States
North Shore University Hospital, Divison of Infectious Diseases
Manhasset, New York, United States
Greiger Clinic
Mount Vernon, New York, United States
Beth Israel Medical Center- Division of Infectious Diseases
New York, New York, United States
Chelsea Village Medical, PC
New York, New York, United States
Ricky K. Hsu, MD
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center - AIDS Center
The Bronx, New York, United States
University of NC AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States
Carolinas Medical Center-Myers Park
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
Summa Health System
Akron, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Palmetto Health Richland
Columbia, South Carolina, United States
AIDS Arms, Inc./ Peabody Health Center
Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Garcia's Family Health Group
Harlingen, Texas, United States
Therapeutic Concepts, P.A.
Houston, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
Annandale, Virginia, United States
Peter Shalit, M.D.
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
East Sydney Doctors
Darlinghurst, New South Wales, Australia
Holdsworth House Medical practice
Darlinghurst, New South Wales, Australia
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia
Albion Street Centre
Surry Hills, New South Wales, Australia
Melbourne Sexual Health Clinic
Carlton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Northside Clinic
Melbourne, Victoria, Australia
Prahran Market Clinic
South Yarra, Victoria, Australia
Medizinische Universität Graz
Graz, , Austria
Medizinische Universitat Wien
Vienna, , Austria
SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, , Austria
CHU Saint-Pierre University Hospital
Brussels, , Belgium
Hôpital Universitaire Erasme - ULB
Ghent, , Belgium
Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz
Rio de Janeiro, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas
São Paulo, , Brazil
São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS
São Paulo, , Brazil
Ubc Downtown I.D. Clinic
Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Maple Leaf Research
Toronto, Ontario, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
Clinique medicale l'Actuel
Montreal, Quebec, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
McGill University Health Centre (MUHC) - Montral Chest Institute
Montreal, Quebec, Canada
Clinique OPUS
Montreal, Quebec, Canada
Epidemiklinikken 5112, Rigshospitalet
Copenhagen, , Denmark
Instituto Dominicano de Estudios Virologicos - IDEV
Santo Domingo, , Dominican Republic
Hôpital de La Croix Rousse
Lyon, , France
CHU Hotel Dieu
Nantes, , France
Archet 1 CHU de Nice - 6ème Niveau
Nice, , France
Hôpital Saint Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Bichat Hospital
Paris, , France
Centre Hospitalier de Tourcoing
Tourcoing, , France
EPIMED GmbH
Berlin, , Germany
University of Bonn
Bonn, , Germany
University of Cologne, Department of Internal Medicine
Cologne, , Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Infektio Research GmbH / Infektiologikum Frankfurt
Frankfurt am Main, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
ICH Study Center Hamburg
Hamburg, , Germany
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, , Germany
MUC Research GmbH
München, , Germany
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
Milan, , Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Rome, , Italy
Comprensorio Amedeo Di Savoia Birago Di Vische
Torino, , Italy
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, , Mexico
Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Hospital de Santa Maria
Lisbon, , Portugal
Servico De Doencas Infecciosas - Hospital De Sao Joao
Porto, , Portugal
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico
HOPE Clinical Research
San Juan, Pr, Puerto Rico
VA Caribbean Healthcare System
San Juan, Pr, Puerto Rico
Hospital Universitari De Bellvitge
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Södersjukhuset
Stockholm, , Sweden
Universitätsklinik für Infektiologie, Universitätsspital Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
University Hospital of Zurich
Zurich, , Switzerland
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
Bangkok, , Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Barts and the London NHS Trust
London, , United Kingdom
Chelsea and Westminster Hospital Foundation Trust
London, , United Kingdom
Courtyard Clinic, St. Georges Hospital
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Countries
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References
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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 Jun;20(3):73-81. doi: 10.1080/15284336.2019.1589232. Epub 2019 Jul 8.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-005114-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-292-0109
Identifier Type: -
Identifier Source: org_study_id
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