Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Last updated: February 3, 2015
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Hiv/aids

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT01309243
GS-US-264-0110
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form

  • Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening

  • No prior use of any approved or experimental anti-HIV drug for any length of time

  • Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPVmutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y

  • Normal ECG

  • Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 5 x the upper limit of the normal range (ULN)

  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

  • Adequate hematologic function

  • Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligibleif serum lipase was ≤ 5 x ULN)

  • Adequate renal function

  • Males and Females of childbearing potential must have agreed to utilize highlyeffective contraception methods (two separate forms of contraception, one of whichmust be an effective barrier method, or be non-heterosexually active, practice sexualabstinence or have a vasectomized partner) from screening throughout the duration ofstudy period and for 12 weeks following the last dose of study drug.

  • Adult (≥ 18 years) males or non-pregnant females

Exclusion

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening

  • Females who were breastfeeding

  • Positive serum pregnancy test (female of childbearing potential)

  • Proven or suspected acute hepatitis in the 30 days prior to study entry

  • Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated toreceive treatment for hepatitis C during the course of the study

  • Subjects experiencing decompensated cirrhosis

  • Had an implanted defibrillator or pacemaker

  • Current alcohol or substance abuse

  • A history of malignancy within the past 5 years or ongoing malignancy other thancutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneoussquamous carcinoma

  • Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to baseline

  • Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/naturalsupplements during the study that are contraindicated or not recommended for use,including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with knownallergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens

  • Participation in any other clinical trial without prior approval from the sponsor wasprohibited while participating in this trial.

  • Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3months of study screening, or expected to receive these agents or systemic steroidsfor immunosuppression during the study (eg, corticosteroids, immunoglobulins, andother immune-based or cytokine-based therapies)

  • Had any other clinical condition or prior therapy that, in the opinion of theInvestigator, would have made the participant unsuitable for the study or unable tocomply with the dosing requirements

Study Design

Total Participants: 799
Study Start date:
February 01, 2011
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales 02010
    Australia

    Site Not Available

  • St Vincent's Hospital, Sydney

    Darlinghurst, 02010
    Australia

    Site Not Available

  • Taylor Square Private Clinic

    Darlinghurst, 02010
    Australia

    Site Not Available

  • Clinical Research - Infectious Diseases Unit Alfred Hospital

    Melbourne, 03004
    Australia

    Site Not Available

  • Northside Clinic

    North Fitzroy, 03068
    Australia

    Site Not Available

  • Prahran Market Clinic

    Prahran, 03181
    Australia

    Site Not Available

  • Albion Street Centre

    Surry Hills, 02010
    Australia

    Site Not Available

  • East Sydney Doctors

    Sydney, 02010
    Australia

    Site Not Available

  • LKH Medical University Graz West, Department of Internal Medicine

    Graz, A-8020
    Austria

    Site Not Available

  • Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

    Innsbruck, A6020
    Austria

    Site Not Available

  • Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

    Vienna, 01090
    Austria

    Site Not Available

  • Institute of Tropical Medicine

    Antwerp, 2000
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc - UCL

    Brussels, 01200
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Leuven, 03000
    Belgium

    Site Not Available

  • Division of HIV/AIDS, St. Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia V6Z2C7
    Canada

    Site Not Available

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Maple Leaf Research Maple Leaf Medical Clinic

    Toronto, Ontario M5G 1K2
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University Health Network/Toronto General Hospital

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • McGill University Health Center, Montreal Chest Institute

    Montreal, Quebec H2X 2P4
    Canada

    Site Not Available

  • Clinique médicale L' Actuel

    Montréal, Quebec H2L 4P9
    Canada

    Site Not Available

  • Clinique médicale L' Actuel

    Montréal, Quebec H2L 4P9
    Canada

    Site Not Available

  • Hopital Raymond Poincare

    Garches, 92380
    France

    Site Not Available

  • Hôpital de la Croix-Rousse

    Lyon, 69288
    France

    Site Not Available

  • Chu Hotel Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU Nice - Archet 1

    Nice, 06200
    France

    Site Not Available

  • HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

    Paris, 75475
    France

    Site Not Available

  • Hopital Bichat Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hopital Saint Antoine- Service Maladies infectieuses

    Paris, 75571
    France

    Site Not Available

  • Hopital Tenon Service des Maladies infectieuses et tropicales

    Paris, 75970
    France

    Site Not Available

  • Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

    Paris cedex 13, 75651
    France

    Site Not Available

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208
    France

    Site Not Available

  • EPIMED GmbH

    Berlin, 12157
    Germany

    Site Not Available

  • Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

    Bonn, 53105
    Germany

    Site Not Available

  • Department of Dermatology University Hospital Essen

    Essen, 45122
    Germany

    Site Not Available

  • Private Practice Gute & Locher & Lutz, Infektiologikum

    Frankfurt am Main, 60311
    Germany

    Site Not Available

  • Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • ICH Study Center

    Hamburg, 20146
    Germany

    Site Not Available

  • Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

    Hamburg, 20246
    Germany

    Site Not Available

  • MUC Research GmbH

    München, 80335
    Germany

    Site Not Available

  • MUC Research GmbH

    München, 80335
    Germany

    Site Not Available

  • Ospedali Riuniti

    Bergamo, 24128
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

    Milan, 20127
    Italy

    Site Not Available

  • I Div Infectious Diseases, Luigi Sacco Hospital

    Milano, 20157
    Italy

    Site Not Available

  • San Gerardo Hospital - Uo Malattie Infettive

    Monza, 20092
    Italy

    Site Not Available

  • Foundation "IRCCS Policlinico San Matteo Hospital"

    Pavia, 27100
    Italy

    Site Not Available

  • National Institute for Infectious Diseases "L. Spallanzani" IRCCS

    Rome, 00149
    Italy

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, PB 2040
    Netherlands

    Site Not Available

  • Hospital de Santa Maria - CHLN, EPE

    Lisbon, 1649-035
    Portugal

    Site Not Available

  • Hospital de Joaquim urbano

    Porto, 4369-004
    Portugal

    Site Not Available

  • Serviço de Doenças Infecciosas, Hospital S. Joao

    Porto, 4200-319
    Portugal

    Site Not Available

  • Clinical Research Puerto Rico

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Hospital General Universitario Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Cataluña, 08907
    Spain

    Site Not Available

  • Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

    Elche, 03202
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario 12 Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Unidad HIV. Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Universitätsklinik für Infektiologie

    Bern, 03010
    Switzerland

    Site Not Available

  • CHUV

    Lausanne, 01011
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zurich, 08091
    Switzerland

    Site Not Available

  • Royal Sussex County Hospital

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Ridu, Wgh

    Edinburgh, EH42XU
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital

    London, Sw10 9NH
    United Kingdom

    Site Not Available

  • Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital

    London, E11 BB
    United Kingdom

    Site Not Available

  • Guys and St Thomas' NHS trust

    London, SE7 4EH
    United Kingdom

    Site Not Available

  • Royal Free NHS Trust,

    London, NW32QG
    United Kingdom

    Site Not Available

  • North Manchester General Hospital

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Spectrum Medical Group

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • AHF Research Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    Hayward, California 94545
    United States

    Site Not Available

  • Living Hope Education and Research Consultants

    Long Beach, California 90813
    United States

    Site Not Available

  • Anthony Mills MD Inc

    Los Angeles, California 90069
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

    Los Angeles, California 90028
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • Lightsource Medical

    Los Angeles, California 90036
    United States

    Site Not Available

  • Oasis Clinic

    Los Angeles, California 90059
    United States

    Site Not Available

  • Orange Coast Medical Group

    Newport Beach, California 92663
    United States

    Site Not Available

  • East Bay AIDS Center

    Oakland, California 94609
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Kaiser Permanente Medical Group

    Sacramento, California 95825
    United States

    Site Not Available

  • University of California, Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • La Playa Medical Group and Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Kaiser Permanente Medical Center, San Francisco

    San Francisco, California 94118
    United States

    Site Not Available

  • Metropolis Medical/Dr.Fritz

    San Francisco, California 94114
    United States

    Site Not Available

  • Apex Research LLC

    Denver, Colorado 80209
    United States

    Site Not Available

  • Capital Medical Associates, PC

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Dupont Circle Physician's Group

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Whitman-Walker Clinic

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Gary J. Richmond, M.D., P.A.

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Midway Immunology and Research Center

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Broward General Medical Center

    Ft. Lauderdale, Florida 33311
    United States

    Site Not Available

  • The Kinder Medical Group

    Miami, Florida 33133
    United States

    Site Not Available

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida 33139
    United States

    Site Not Available

  • Orlando Immunology Center

    Orlando, Florida 32803
    United States

    Site Not Available

  • Valuhealthmd,Llc / Idocf

    Orlando, Florida 32806
    United States

    Site Not Available

  • Infectious Disease Associates of NW FL

    Pensacola, Florida 32504
    United States

    Site Not Available

  • AHF Health Positive - Tampa Bay

    Safety Harbor, Florida 34695
    United States

    Site Not Available

  • St. Joseph's Hospital d/b/a Comprehensive Research Institute

    Tampa, Florida 33614
    United States

    Site Not Available

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Atlanta ID Group

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30306
    United States

    Site Not Available

  • Infectious Disease Specialists of America

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Mercer University School of Medicine

    Macon, Georgia 31201
    United States

    Site Not Available

  • Clint Spencer Clinic

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Howard Brown Health Center

    Chicago, Illinois 60613
    United States

    Site Not Available

  • Northstar Medical Center

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Community Research Initiative of New England

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Claudia T Martorell, MD., LLC dba The Research Institute

    Springfield, Massachusetts 01105
    United States

    Site Not Available

  • Be Well Medical Center

    Berkley, Michigan 48072
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Central West Clinical Research, Inc.

    St. Louis, Missouri 63108
    United States

    Site Not Available

  • Southampton Healthcare

    St. Louis, Missouri 63139
    United States

    Site Not Available

  • Saint Michael's Medical Center

    Newark, New Jersey 07102
    United States

    Site Not Available

  • South Jersey Infectious Disease

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • Southwest Care Center

    Sante Fe, New Mexico 87505
    United States

    Site Not Available

  • Upstate Infectious Disease Associates

    Albany, New York 12208
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York Hospital Queens

    Flushing, New York 11355
    United States

    Site Not Available

  • North Shore University Hospital--Division of Infectious Diseases

    Manhasset, New York 11030
    United States

    Site Not Available

  • Greiger Clinic

    Mount Vernon, New York 10550
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Ricky K. Hsu, Md, Pc

    New York, New York 10011
    United States

    Site Not Available

  • Clinical and Translational Research Center - UNC Hospitals

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The Brody School of Medicine at East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Rosedale Infectious Diseases

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Summa Health System Care Center

    Akron, Ohio 44203
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of South Carolina

    Columbia, South Carolina 29223
    United States

    Site Not Available

  • Central Texas Clinical Research

    Austin, Texas 78705
    United States

    Site Not Available

  • Southwest Infectious Disease Associates, Inc.

    Dallas, Texas 75219
    United States

    Site Not Available

  • Trinity Health and Wellness Center

    Dallas, Texas 75208
    United States

    Site Not Available

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Garcia Family Health Group

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Gordon E. Crofoot MD PA

    Houston, Texas 77098
    United States

    Site Not Available

  • Therapeutic Concepts, P.A.

    Houston, Texas 77004
    United States

    Site Not Available

  • DCOL Center for Clinical Research

    Longview, Texas 75605
    United States

    Site Not Available

  • CARE-ID

    Annandale, Virginia 22003
    United States

    Site Not Available

  • Peter Shalit, M.D.

    Seattle, Washington 98104
    United States

    Site Not Available

  • Rockwood Pulmonary and Critical Care

    Spokane, Washington 99204
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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