Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Last updated: May 6, 2016
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT01475838
GS-US-236-0115
2011-004483-30
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form

  • Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plusFTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit

  • Be on the first or second antiretroviral drug regimen documented undetectable plasmaHIV 1 RNA levels for ≥ 6 months preceding the screening visit

  • No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time

  • Documented historical genotype prior to starting initial antiretroviral therapyshowing no known resistance to TDF or FTC

  • HIV RNA < 50 copies/mL at screening

  • Normal ECG

  • Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)

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

  • Adequate hematologic function

  • Serum amylase ≤ 5 × ULN

  • Estimated glomerular filtration rate ≥ 70 mL/min

  • Females of childbearing potential must agree to utilize highly effective contraceptionmethods, or be nonheterosexually active, practice sexual abstinence from screeningthroughout the duration of the study period and for 30 days following the last dose ofstudy drug

  • Female participants who utilize hormonal contraceptive as one of their birth controlmethods must have used the same method for at least three months prior to study dosing

  • Male participants must agree to utilize a highly effective method of contraceptionduring heterosexual intercourse from the screening visit, throughout the duration ofthe study and for 30 days following discontinuation of investigational medicinalproduct, or must be nonheterosexually active, or practice sexual abstinence

  • Age ≥ 18 years

Exclusion

Exclusion Criteria:

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

  • Females who are breastfeeding

  • Positive serum pregnancy test (female of childbearing potential)

  • Receiving drug treatment for hepatitis C, or participants who are anticipated toreceive treatment for hepatitis C during the course of the study

  • Experiencing decompensated cirrhosis

  • Have an implanted defibrillator or pacemaker

  • Current alcohol or substance abuse that would interfere with compliance

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

  • Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to Baseline, except for intramuscular penicillin for thetreatment of syphilis

  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3months of study screening, or expected to receive these agents or systemic steroidsduring the study

  • Receiving ongoing therapy with any of the medications, including drugs not to be usedwith elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to theexcipients of E/C/F/TDF tablets, or FTC/TDF tablets

  • No anticipated need to initiate drugs during the study that are contraindicated

  • Receiving other investigational drugs

  • Participation in any other clinical trial

  • Any other clinical condition or prior therapy that would make the participantunsuitable for the study or unable to comply with the dosing requirements

Study Design

Total Participants: 438
Study Start date:
November 01, 2011
Estimated Completion Date:
December 31, 2014

Connect with a study center

  • Innsbruck Medical University

    Innsbruck, A 6020
    Austria

    Site Not Available

  • Univ.-Kklinik fuer Innere Medizin III

    Salzburg, 5020
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • Otto-Wagner-Spital

    Wien, 1140
    Austria

    Site Not Available

  • UCL Saint Luc

    Brussels, 01200
    Belgium

    Site Not Available

  • University Hospital Ghent

    Ghent, 9000
    Belgium

    Site Not Available

  • CHU Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec H2L 5B1
    Canada

    Site Not Available

  • CHU de Besancon, Hopital Saint-Jacques

    Besançon, 25030
    France

    Site Not Available

  • Hôpital de la Croix-Rousse

    Lyon, 69317
    France

    Site Not Available

  • CHU Hôpital Gui de Chauliac

    Montpellier, 34295
    France

    Site Not Available

  • Archet 1 Chu Nice Department of Infectology

    Nice, 06202
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • Hôpital Bichat-Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Saint-Louis Hospital

    Paris, 75010
    France

    Site Not Available

  • hôpital Tenon

    Paris, 75020
    France

    Site Not Available

  • Maladies Infectieuses Dpt

    Paris Cedex 13, 75651
    France

    Site Not Available

  • Hôpital Haut Lévêque

    Pessac, 33604
    France

    Site Not Available

  • Epimed GmbH

    Berlin, 12157
    Germany

    Site Not Available

  • University of Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

    Essen, 45147
    Germany

    Site Not Available

  • Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

    Frankfurt, 60590
    Germany

    Site Not Available

  • ICH Study Center

    Hamburg, 20146
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

    Hamburg, 20246
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Infektlonsambulanz Unlkllnik Koln

    Koln, 50937
    Germany

    Site Not Available

  • Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

    Munich, 80336
    Germany

    Site Not Available

  • Ospedali Riuniti

    Bergamo, 24128
    Italy

    Site Not Available

  • Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

    Milan, 20142
    Italy

    Site Not Available

  • Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

    Milano, 20142
    Italy

    Site Not Available

  • Fondazione Centro San Raffaele

    Milano, 20127
    Italy

    Site Not Available

  • Ospedale Luigi Sacco

    Milano, 20157
    Italy

    Site Not Available

  • National Institute for Infectious Diseases "L. Spallanzani"

    Rome, 00149
    Italy

    Site Not Available

  • University of Torino, Dept of Infectious Disease

    Torino, 10122
    Italy

    Site Not Available

  • HHP Hospital de Cascais

    Alcabideche, 2755
    Portugal

    Site Not Available

  • Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

    Lisboa, 1150-069
    Portugal

    Site Not Available

  • Hospital de Santa Maria-CHLN, EPE

    Lisbon, 1049-035
    Portugal

    Site Not Available

  • Clinical Research Puert Rico

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • University of Puerto Rico School of Medicine

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Hospital General Universitario Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Germans Trias I Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital clinic

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid, 28760
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Infectious Diseases Department, Hospital Carlos III

    Madrid, 28029
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Geneva University Hospital

    Geneva, 1205
    Switzerland

    Site Not Available

  • University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology

    Zurich, 8091
    Switzerland

    Site Not Available

  • Zentrum fur Infektionskrankheiten

    Zurich, CH-8038
    Switzerland

    Site Not Available

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN21ES
    United Kingdom

    Site Not Available

  • Chelsea and Westminster

    London, SW109NH
    United Kingdom

    Site Not Available

  • Royal Free Hampstead NHS Trust

    London, NW32QG
    United Kingdom

    Site Not Available

  • Pueblo Family Physicians

    Phoenix, Arizona 85015
    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

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Pacific Oaks Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Kaiser Permanente

    Hayward, California 94545
    United States

    Site Not Available

  • Anthony Mills MD Inc

    Los Angeles, California 90069
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • OASIS Clinic

    Los Angeles, California 90043
    United States

    Site Not Available

  • Peter J. Ruane, M.D., Inc.

    Los Angeles, California 90036
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Kaiser Permanente

    Sacramento, California 95841
    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 San Francisco

    San Francisco, California 94118
    United States

    Site Not Available

  • Metropolis Medical

    San Francisco, California 94109
    United States

    Site Not Available

  • Capital Medical Associates, PC

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Dupont Circle Physicians Group, P.C

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Gary Richmond, MD

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Midway Immunology & Research Center, LLC

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • The Kinder Medical Group

    Miami, Florida 33133
    United States

    Site Not Available

  • Idocf/Valuhealthmd, Llc

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Immunology Center

    Orlando, Florida 32803
    United States

    Site Not Available

  • Infectious Diseases Associates of NW FL, P.A.

    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 Comprehensive Research Institute

    Tampa, Florida 33614
    United States

    Site Not Available

  • Atlanta ID Group

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Northwestern University Division of Infectious Diseases

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Be Well Medical Center

    Berkley, Michigan 48072
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • The Kansas City Free Health Clinic

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • I.D. Care Associates PA

    Hillsborough, New Jersey 08844
    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

  • Greiger Clinic

    Mt. Vernon, New York 10550
    United States

    Site Not Available

  • ID Consultants, P.A.

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    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

  • Southwest Infectious Disease Clinical Research, Inc

    Dallas, Texas 75219
    United States

    Site Not Available

  • Uptown Physicians Group

    Dallas, Texas 75204
    United States

    Site Not Available

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Gordon Crofoot Md, Pa

    Houston, Texas 77098
    United States

    Site Not Available

  • St. Hope Foundation Inc

    Houston, Texas 77401
    United States

    Site Not Available

  • Therapeutic Concepts, PA

    Houston, Texas 77004
    United States

    Site Not Available

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