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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01815736
First received: March 19, 2013
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

This randomized, open-label, active-controlled study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-Containing Combination single tablet regimen (STR) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 following the switch.


Condition Intervention Phase
HIV
HIV Infections
Drug: E/C/F/TAF
Drug: E/C/F/TDF, EFV/FTC/TDF, ritonavir + atazanavir + FTC/TDF, or cobicistat + atazanavir + FTC/TDF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-containing Combination Regimens to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-suppressed, HIV-1 Positive Subjects

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The proportion of participants who have HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in hip bone mineral density [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine bone mineral density [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in efavirenz-related symptom assessment score [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will switch to STR of E/C/F/TAF for 48 weeks
Drug: E/C/F/TAF
Single-tablet regimen of E/C/F/TAF containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg administered orally once daily
Active Comparator: E/C/F/TDF, EFV/FTC/TDF, ATV/r+FTC/TDF or ATV/co+FTC/TDF
Maintain pre-existing regimen [elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF), ritonavir-boosted atazanavir (ATV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), or cobicistat-boosted atazanavir (ATV/co) + FTC/TDF] for 48 weeks
Drug: E/C/F/TDF, EFV/FTC/TDF, ritonavir + atazanavir + FTC/TDF, or cobicistat + atazanavir + FTC/TDF
Other Names:
  • Stribild™ (E/C/F/TDF)
  • Atripla® (EFV/FTC/TDF)
  • Truvada® (FTC/TDF)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, ATV/r + FTC/TDF, or ATV/co + 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 subjects on an efavirenz-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105
  • Plasma 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 (AST and ALT) ≤ 5 × upper limit of the normal range (ULN)
  • Direct bilirubin ≤ 1.5 mg/dL
  • 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 30 days following the last dose of study drug
  • Female subjects 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 subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
  • Age ≥ 18 years

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen position
  • Hepatitis C antibody positive
  • Subjects 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
  • Subjects receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), cobicistat (COBI), FTC, TDF, ATV, ritonavir (RTV), EFV, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF STR, E/C/F/TAF STR, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815736

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States, 85006
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
Kaiser Permanente Hospital
Hayward, California, United States, 94545
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J Ruane, MD, Inc
Los Angeles, California, United States, 90036
Kaiser Permanente
Los Angeles, California, United States, 90027
Orange Coast Medical Group
Newport Beach, California, United States, 92663
East Bay AIDS Center
Oakland, California, United States, 94609
Alameda County Medical Center
Oakland, California, United States, 94602
Stanford University
Palo Alto, California, United States, 94303
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
University of California, Davis Medical Center
Sacramento, California, United States, 95817
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
United States, Colorado
Apex Research LLC
Denver, Colorado, United States, 80209
United States, Connecticut
Stamford Hospital
Greenwich, Connecticut, United States, 06830
Yale University HIV Clinical Trials Program
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States, 33316
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
The Kinder Medical Group
Miami, Florida, United States, 33133
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ Value Health MD, LLC
Orlando, Florida, United States, 32806
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33615
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
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
NorthStar Medical Center
Chicago, Illinois, United States, 60657
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
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
St. Louis, Missouri, United States, 63108
Southampton Healthcare
St. Louis, Missouri, United States, 63139
Saint Louis University
St. Louis, Missouri, United States, 63110
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
Albany Medical College
Albany, New York, United States, 12209
Upstate ID Association
Albany, New York, United States, 12208
Montefiore Medical Center - AIDS Center
Bronx, New York, United States, 10467
Jacobi Medical Center
Bronx, New York, United States, 10461
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
Chelsea Village Medical, PC
New York, New York, United States, 10011
Ricky K. Hsu, MD
New York, New York, United States, 10011
Beth Israel Medical Center- Division of Infectious Diseases
New York, New York, United States, 10003
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
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
United States, Texas
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75219
AIDS Arms, Inc./ Peabody Health Center
Dallas, Texas, United States, 75215
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Garcia's Family Health Group
Harlingen, Texas, United States, 78550
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Therapeutic Concepts, P.A.
Houston, Texas, United States, 77004
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
Rockwood Pulmonary and Critical Care
Spokane, Washington, United States, 99204
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 - Centro de Referência e Treinamento em DST/AIDS
Sao Paulo, Brazil, 04121-000
São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas
Sao Paulo, Brazil, 01246-900
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
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Maple Leaf Research
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 4P9
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
Hopital Saint Antoine
Paris, France, 75012
Hôpital Saint Louis
Paris, France, 75010
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
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, Germany, 20246
ICH Study Center Hamburg
Hamburg, Germany, 20146
University of Cologne, Department of Internal Medicine
Köln, Germany, 50937
MUC Research GmbH
München, Germany, 80335
Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy, 20127
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
Milano, Italy, 20157
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
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
HOPE Clinical Research
San Juan, Puerto Rico, 00909
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
Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine
Bangkok, Thailand, 10700
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
Bangkok, Thailand, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
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
Chelsea and Westminster Hospital Foundation Trust
London, United Kingdom, SW10 9NH
Courtyard Clinic, St. Georges Hospital
London, United Kingdom, SW17 0QT
Barts and the London NHS Trust
London, United Kingdom, E1 1BB
Homerton University Hospital
London, United Kingdom, E9 6SR
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Scott McCallister, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01815736     History of Changes
Other Study ID Numbers: GS-US-292-0109, 2012-005114-20
Study First Received: March 19, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
HIV 1 Infected
Virologically-Suppressed

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Emtricitabine
Ritonavir
Tenofovir disoproxil
Atazanavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014