AzTrials
AzTrials

HIVPhase 3NCT01815736

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

A Phase 3 study testing E/C/F/TAF, E/C/F/TDF and EFV/FTC/TDF in people with HIV and HIV Infections, run by Gilead Sciences at 167 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
E/C/F/TAF, E/C/F/TDF and EFV/FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,443 participants
Where
167 sitesin 20 countries
Study dates
27 Mar 2013to 1 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

167 sites in 20 countries.

167 sites in 20 countries

United States91 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Upstate ID Association

    Albany, New York, 12208

  • Albany Medical College

    Albany, New York, 12209

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

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02111

  • University of NC AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center-Myers Park

    Charlotte, North Carolina, 28207

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • NorthStar Medical Center

    Chicago, Illinois, 60657

  • Palmetto Health Richland

    Columbia, South Carolina, 29203

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

    Costa Mesa, California, 92626

  • AIDS Arms, Inc./ Peabody Health Center

    Dallas, Texas, 75215

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas, 75219

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Apex Research LLC

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Health System

    Durham, North Carolina, 27710

  • New York Hospital Queens

    Flushing, New York, 11355

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Broward Health/Comprehensive Care Center

    Fort Lauderdale, Florida, 33311

  • Gary J. Richmond,M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University

    Greenville, North Carolina, 27834

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Garcia's Family Health Group

    Harlingen, Texas, 78550

  • ID Care

    Hillsborough, New Jersey, 08844

  • University of Hawaii - Hawaii Center for AIDS

    Honolulu, Hawaii, 96816

  • Therapeutic Concepts, P.A.

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Health for Life Clinic PLLC

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • Peter J Ruane, MD, Inc

    Los Angeles, California, 90036

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital, Divison of Infectious Diseases

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Yale University HIV Clinical Trials Program

    New Haven, Connecticut, 06510

  • Beth Israel Medical Center- Division of Infectious Diseases

    New York, New York, 10003

  • Chelsea Village Medical, PC

    New York, New York, 10011

  • Ricky K. Hsu, MD

    New York, New York, 10011

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Alameda County Medical Center

    Oakland, California, 94602

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ Value Health MD, LLC

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94303

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona, 85006

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical Group

    San Francisco, California, 94109

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California, 94118

  • Kaiser Permanente Hospital

    San Leandro, California, 94577

  • SouthWest CARE Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Premier Clinical Research

    Spokane, Washington, 99202

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • Central West Clinical Research

    St Louis, Missouri, 63108

  • Saint Louis University

    St Louis, Missouri, 63110

  • Southampton Healthcare

    St Louis, Missouri, 63139

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

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33615

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center - AIDS Center

    The Bronx, New York, 10467

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

Canada10 sites

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L 4P9

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • McGill University Health Centre (MUHC) - Montral Chest Institute

    Montreal, Quebec, H2X 2P4

  • Clinique OPUS

    Montreal, Quebec, H3A 1T1

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Maple Leaf Research

    Toronto, Ontario, M5G 1K2

  • University Health Network, Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Ubc Downtown I.D. Clinic

    Vancouver, British Columbia, V6Z 2C7

  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Germany10 sites

  • EPIMED GmbH

    Berlin, 12157

  • University of Bonn

    Bonn, 53127

  • University of Cologne, Department of Internal Medicine

    Cologne, 50937

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

  • Infektio Research GmbH / Infektiologikum Frankfurt

    Frankfurt am Main, 60311

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • ICH Study Center Hamburg

    Hamburg, 20146

  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

    Hamburg, 20246

  • MUC Research GmbH

    München, 80335

Other trials in Germany

Australia9 sites

  • Melbourne Sexual Health Clinic

    Carlton, Victoria, 3053

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • Holdsworth House Medical practice

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2010

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Northside Clinic

    Melbourne, Victoria, 3068

  • Prahran Market Clinic

    South Yarra, Victoria, 3141

  • Albion Street Centre

    Surry Hills, New South Wales, 2010

Other trials in Australia

France7 sites

  • Hôpital de La Croix Rousse

    Lyon, 75970

  • CHU Hotel Dieu

    Nantes, 44093

  • Archet 1 CHU de Nice - 6ème Niveau

    Nice, 06200

  • Hôpital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

  • Bichat Hospital

    Paris, 75018

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Thailand5 sites

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

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine

    Bangkok, 10700

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

    Chiang Mai, 50200

  • Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

United Kingdom5 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 1ES

  • Barts and the London NHS Trust

    London, E1 1BB

  • Chelsea and Westminster Hospital Foundation Trust

    London, SW10 9NH

  • Courtyard Clinic, St. Georges Hospital

    London, SW17 0QT

  • North Manchester General Hospital

    Manchester, M8 5RB

Other trials in United Kingdom

Brazil4 sites

  • Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz

    Rio de Janeiro, 21040-360

  • Faculdade de Medicina do ABC

    Santo André, 09060-650

  • São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas

    São Paulo, 01246-900

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

    São Paulo, 04121-000

Other trials in Brazil

Italy4 sites

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

    Milan, 20157

  • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

    Rome, 00149

  • Comprensorio Amedeo Di Savoia Birago Di Vische

    Torino, 10149

Other trials in Italy

Austria3 sites

  • Medizinische Universität Graz

    Graz, 8020

  • Medizinische Universitat Wien

    Vienna, 1090

  • SMZ Baumgartner Hoehe - Otto-Wagner-Spital

    Vienna, 1140

Other trials in Austria

Puerto Rico3 sites

  • Clinical Research Puerto Rico

    San Juan, PR, 00909

  • HOPE Clinical Research

    San Juan, Pr, 00909

  • VA Caribbean Healthcare System

    San Juan, Pr, 00921

Other trials in Puerto Rico

Spain3 sites

  • Hospital Universitari De Bellvitge

    Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Switzerland3 sites

  • Universitätsklinik für Infektiologie, Universitätsspital Bern

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • University Hospital of Zurich

    Zurich, 8091

Other trials in Switzerland

Belgium2 sites

  • CHU Saint-Pierre University Hospital

    Brussels, 1000

  • Hôpital Universitaire Erasme - ULB

    Ghent, 1070

Other trials in Belgium

Netherlands2 sites

  • Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten

    Amsterdam, 1091 AC

  • Erasmus MC

    Rotterdam, 3000 CA

Other trials in Netherlands

Portugal2 sites

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Servico De Doencas Infecciosas - Hospital De Sao Joao

    Porto, 4202-451

Other trials in Portugal

Denmark1 site

  • Epidemiklinikken 5112, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Dominican Republic1 site

  • Instituto Dominicano de Estudios Virologicos - IDEV

    Santo Domingo

Other trials in Dominican Republic

Mexico1 site

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, 44280

Other trials in Mexico

Sweden1 site

  • Södersjukhuset

    Stockholm, 11883

Other trials in Sweden

About this study

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

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.

Conditions
HIV, HIV Infections
Being tested
E/C/F/TAF, E/C/F/TDF, EFV/FTC/TDF, RTV, ATV
Keywords
HIV, HIV 1 Infected, Virologically-Suppressed
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E/C/F/TAFDrug

    Also called EVG/COBI/FTC/TAF; Genvoya®

    150/150/200/10 mg FDC tablet administered orally once daily

  • E/C/F/TDFDrug

    Also called Stribild®

    150/150/200/300 mg FDC tablet administered orally once daily

  • EFV/FTC/TDFDrug

    Also called Atripla®

    600/200/300 mg FDC tablet administered orally once daily

  • RTVDrug

    Also called Norvir®

    100 mg tablet administered orally once daily

  • ATVDrug

    Also called Reyataz®

    300 mg capsule administered orally once daily

  • FTC/TDFDrug

    Also called Truvada®

    200/300 mg tablet administered orally once daily

  • COBIDrug

    Also called Tybost®, GS-9350

    150 mg tablet administered orally once daily

Study groups in NCT01815736
Study groupRoleWhat they receive
E/C/F/TAFExperimentalRandomized 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.
Receives: Drug: E/C/F/TAF
Stay on Baseline Treatment Regimen (SBR)Active comparatorRandomized 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.
Receives: Drug: E/C/F/TDF; Drug: EFV/FTC/TDF; Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 48

Secondary outcomes (9)

  1. 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.

    Measured: Baseline; Week 48

  2. 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.

    Measured: Baseline; Week 48

  3. Change From Baseline in Serum Creatinine at Week 48

    Measured: Baseline; Week 48

  4. 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.

    Measured: Baseline; Week 48

  5. 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.

    Measured: Week 96

  6. 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.

    Measured: Week 48

  7. 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.

    Measured: Week 96

  8. 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.

    Measured: Baseline; Week 48

  9. 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.

    Measured: Baseline; Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2013 (estimated)
  2. Study start27 Mar 2013
  3. Primary completion16 Mar 2015
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815736
Sponsor's protocol ID
GS-US-292-0109
Other IDs
2012-005114-20
Status last verified
Mar 2021
First submitted
19 Mar 2013
Last updated
13 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 26538525

  • 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.

    PubMed 28259777

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF, E/C/F/TDF and EFV/FTC/TDF in people with HIV and HIV Infections, run by Gilead Sciences at 167 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Canada, Germany, Australia, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815736, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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Clinical Trial NCT01815736 | AzTrials