Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

Last updated: October 27, 2015
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Hiv/aids

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT01252940
GS-US-264-0106
2010-023178-37
  • Ages > 18
  • All Genders

Study Summary

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form

  • Receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIscontinuously for ≥ 6 months preceding the screening visit

  • Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 6 months prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screeningvisit

  • On their first or second antiretroviral drug regimen; if on their second regimen,HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviraldrugs, and no HIV RNA > 50 copies/mL measured at two consecutive time points afterfirst achieving HIV RNA < 50 copies/mL

  • No previous use of any approved or experimental nonnucleoside reverse transcriptaseinhibitor (NNRTI) drug for any length of time

  • Have a genotype prior to starting initial antiretroviral therapy and no knownresistance to any of the study agents

  • Normal ECG

  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

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

  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

  • Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serumlipase ≤ 5 x ULN)

  • Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according tothe Cockcroft-Gault formula)

  • Males and females of childbearing potential must agree to utilize highly effectivecontraception methods (two separate forms of contraception, one of which must havebeen an effective barrier method, or been nonheterosexually active, practice sexualabstinence, or have a vasectomized partner) from screening throughout the duration ofthe study period and for 30 days following the last dose of study drug.

  • Age ≥ 18 years

  • Life expectancy ≥ 1 year

Exclusion

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within 30 days prior to screening exceptcluster of differentiation 4 (CD4) cell count and/or percentage criteria

  • Females who are breastfeeding

  • Positive serum pregnancy test (female of childbearing potential)

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

  • Current alcohol or substance abuse judged by the Investigator to potentially interferewith subject compliance.

  • History of malignancy within 5 years prior to study entry or ongoing malignancy otherthan cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasivecutaneous squamous carcinoma

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

  • Anticipated need to initiate contraindicated drugs during the study, including drugsnot to be used with FTC, TDF, RPV; or subjects with known allergies to the excipientsof FTC/RPV/TDF STR tablets or Truvada® tablets

  • All investigational drugs

  • Medications and use of herbal/natural supplements excluded or to be used with cautionwhile participating in the study, including those not to be taken with Viread®,Emtriva®, Truvada, and Rilpivirine.

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

  • Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 monthsof study screening, or expected to receive these agents or systemic steroids duringthe study

  • History of liver disease, including Gilbert's Disease

  • Any other clinical condition or prior therapy making the subject unsuitable for thestudy or unable to comply with the dosing requirements

Study Design

Total Participants: 482
Study Start date:
November 01, 2010
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • Univ.-Kklinik fuer Innere Medizin III

    Salzberg,
    Austria

    Site Not Available

  • LKH Graz West

    Styria,
    Austria

    Site Not Available

  • 2.Interne Lungenabteilung Otto Wagner Spital

    Vienna,
    Austria

    Site Not Available

  • Dept. of Dermatology, Div. of Immunology,

    Vienna,
    Austria

    Site Not Available

  • Private Office

    Vienna,
    Austria

    Site Not Available

  • CHU Saint-Pierre University Hospital

    Brussels, 1000
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Flemish Brabant,
    Belgium

    Site Not Available

  • Universitaire Ziekenhuis Gent

    Ghent, 9000
    Belgium

    Site Not Available

  • Downtown Infectious Disease Clinic - Univ of BC

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Maple Leaf Research

    Toronto, Ontario
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Site Not Available

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec H2L 5B1
    Canada

    Site Not Available

  • Winnipeg Regional Health Authority

    Winnipeg,
    Canada

    Site Not Available

  • Hôpital Hôtel-Dieu

    Lyon, 69002
    France

    Site Not Available

  • Infectiologie - 7ème Ouest - CHU HOTEL DIEU

    Nantes,
    France

    Site Not Available

  • Archet 1 CHU de Nice - 6ème Niveau - Infectiology

    Nice Cedex 3, 06202
    France

    Site Not Available

  • Bichat Hospital

    Paris, 75018
    France

    Site Not Available

  • Department of Infectious Diseases, Saint-Louis hospital

    Paris, 75010
    France

    Site Not Available

  • Hopital Tenon

    Paris,
    France

    Site Not Available

  • Hôpital Saint Antoine, Servuce de Maladies Infectieuses

    Paris, 75012
    France

    Site Not Available

  • Maladies Infectieuses Dpt

    Paris,
    France

    Site Not Available

  • Hôpital Haut Levêque

    Pessac,
    France

    Site Not Available

  • EPIMED GmbH

    Berlin, 12157
    Germany

    Site Not Available

  • University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

    Bonn, 53127
    Germany

    Site Not Available

  • Center for HIV and Hepatogastroenterology

    Dusseldorf,
    Germany

    Site Not Available

  • Infectio Research

    Frankfurt, 60596
    Germany

    Site Not Available

  • ICH Study Center Hamburg

    Hamburg, 20146
    Germany

    Site Not Available

  • University Medical Center Hamburg - Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • University of Cologne, Department of Internal Medicine

    Köln, 50937
    Germany

    Site Not Available

  • University of Cologne, Department of Internal Medicine

    Köln, 50937
    Germany

    Site Not Available

  • Ospedali Riuniti

    Bergamo, 24128
    Italy

    Site Not Available

  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

    Milan, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali

    Milan, 20142
    Italy

    Site Not Available

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127
    Italy

    Site Not Available

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

    Rome, 20149
    Italy

    Site Not Available

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 28036
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol

    Barcelona, 28916
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, East Sussex BN2 1ES
    United Kingdom

    Site Not Available

  • Barts and the London NHS Trust

    London, E1 1BB
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital Foundation Trust

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Homerton Unversity Hospital

    London,
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • North Manchester General Hospital

    Manchester, M85RB
    United Kingdom

    Site Not Available

  • University of Alabama - Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Spectrum Medical Group

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Health for Life Clinic, PLLC

    Little Rock, Arkansas 72207
    United States

    Site Not Available

  • AIDS Healthcare Foundation-Research Center

    Beverly HIlls, California 90211
    United States

    Site Not Available

  • Pacific Oaks Medical Group

    Beverly Hills, California
    United States

    Site Not Available

  • Center for Special Immunology

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Kaiser Permanente

    Hayward, California 94545
    United States

    Site Not Available

  • The Living Hope Foundation

    Long Beach, California 90813
    United States

    Site Not Available

  • Anthony Mills, MD Internal Medicine

    Los Angeles, California 90069
    United States

    Site Not Available

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California 90028
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • Oasis Clinic

    Los Angeles, California 90059
    United States

    Site Not Available

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California 90019
    United States

    Site Not Available

  • Orange Coast Medical Group

    Newport Beach, California 92663
    United States

    Site Not Available

  • Alameda County Medical Center

    Oakland, California 94602
    United States

    Site Not Available

  • East Bay AIDS Center

    Oakland, California 94609
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94303
    United States

    Site Not Available

  • Kaiser Permanente

    Sacramento, California 95825
    United States

    Site Not Available

  • University of California, Davis

    Sacramento, California 95187
    United States

    Site Not Available

  • La Playa Medical Group and Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Kaiser Permanente

    San Francisco, California 94118
    United States

    Site Not Available

  • Metropolis Medical

    San Francisco, California 94115
    United States

    Site Not Available

  • Capital Medical Associates PC

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Midway Immunology & Research Center

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Care Resource

    Miami, Florida
    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

  • ValueHealthMD, LLC/IDOCF

    Orlando, Florida 32806
    United States

    Site Not Available

  • Wade, Barbara Private Practice

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Barry M. Rodwick, M.D.

    Safety Harbor, Florida 34695
    United States

    Site Not Available

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida 33614
    United States

    Site Not Available

  • University of South Florida - HIV Clinical Research Unit

    Tampa, Florida 33062
    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

  • Infectious Disease Specialists of Atlanta (IDSA)

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Mercer Univ. School of Medicine

    Macon, Georgia 31201
    United States

    Site Not Available

  • Northstar Medical Center

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The Ruth M. Rothstein CORE Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • 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 Hospital Div of Infectious Disease

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Kansas City Free Health Clinic

    Kansas City, Missouri
    United States

    Site Not Available

  • Southampton Healthcare, Inc.

    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

    Somer Point, New Jersey 08244
    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

    Mt Vernon, New York
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • The Aaron Diamond AIDS Research Center

    New York, New York 10016
    United States

    Site Not Available

  • ID Consultant, P.A.

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Duke University Health System, Division of Infectious Disease Clinic 2J

    Durham, North Carolina 27710
    United States

    Site Not Available

  • East Carolina University, The Brody School of Medicine

    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 CARE Center

    Akron, Ohio 44304
    United States

    Site Not Available

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of South Carolina

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Central Texas Clinical Research

    Austin, Texas 78705
    United States

    Site Not Available

  • Nicholaos Bellos, MD, PA

    Dallas, Texas 75204
    United States

    Site Not Available

  • Tarrant County Infectious Diseases Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Garcia Family Medical Clinic

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Gordon E. Crofoot, MD, PA

    Houston, Texas 77098
    United States

    Site Not Available

  • Research Access Network

    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

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

    Annandale, Virginia 22003
    United States

    Site Not Available

  • TribalMed

    Seattle, Washington 98104
    United States

    Site Not Available

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