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

May 6, 2016 updated by: Gilead Sciences

A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A 6020
        • Innsbruck Medical University
      • Salzburg, Austria, 5020
        • Univ.-Kklinik fuer Innere Medizin III
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Wien, Austria, 1140
        • Otto-Wagner-Spital
  • Belgium
      • Brussels, Belgium, 01200
        • UCL Saint Luc
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Liege, Belgium, 4000
        • CHU Sart Tilman
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 5B1
        • Clinique Medicale du Quartier Latin
  • France
      • Besançon, France, 25030
        • CHU de Besancon, Hopital Saint-Jacques
      • Lyon, France, 69317
        • Hôpital de la Croix-Rousse
      • Montpellier, France, 34295
        • CHU Hôpital Gui de Chauliac
      • Nice, France, 06202
        • Archet 1 Chu Nice Department of Infectology
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75018
        • Hopital Bichat-Claude Bernard
      • Paris, France, 75010
        • Saint-Louis Hospital
      • Paris Cedex 13, France, 75651
        • Maladies Infectieuses Dpt
      • Pessac, France, 33604
        • Hopital Haut Leveque
  • Germany
      • Berlin, Germany, 12157
        • EPIMED GmbH
      • Bonn, Germany, 53127
        • University of Bonn
      • Essen, Germany, 45147
        • Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
      • Frankfurt, Germany, 60590
        • Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
      • Hamburg, Germany, 20146
        • ICH Study Center
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Koln, Germany, 50937
        • Infektlonsambulanz Unlkllnik Koln
      • Munich, Germany, 80336
        • Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
  • Italy
      • Bergamo, Italy, 24128
        • Ospedali Riuniti
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
      • Milano, Italy, 20127
        • Fondazione Centro San Raffaele
      • Milano, Italy, 20142
        • Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
      • Rome, Italy, 00149
        • National Institute for Infectious Diseases "L. Spallanzani"
      • Torino, Italy, 10122
        • University of Torino, Dept of Infectious Disease
  • Portugal
      • Alcabideche, Portugal, 2755
        • HHP Hospital de Cascais
      • Lisboa, Portugal, 1150-069
        • Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
      • Lisbon, Portugal, 1049-035
        • Hospital de Santa Maria-CHLN, EPE
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico School of Medicine
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puert Rico
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Alicante
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
      • Elche, Alicante, Spain, 03202
        • Hospital General Universitario de Elche
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28029
        • Infectious Diseases Department, Hospital Carlos III
      • Madrid, Spain, 28760
        • Hospital La Paz
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva University Hospital
      • Zurich, Switzerland, 8091
        • University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
      • Zurich, Switzerland, CH-8038
        • Zentrum fur Infektionskrankheiten
  • United Kingdom
      • Brighton, United Kingdom, BN21ES
        • Brighton and Sussex University Hospitals NHS Trust
      • London, United Kingdom, NW32QG
        • Royal Free Hampstead NHS Trust
      • London, United Kingdom, SW109NH
        • Chelsea and Westminster
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Spectrum Medical Group
      • Phoenix, Arizona, United States, 85015
        • Pueblo Family Physicians
    • California
      • Beverly Hills, California, United States, 90211
        • AIDS Healthcare Foundation
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Medical Group
      • Hayward, California, United States, 94545
        • Kaiser Permanente
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Los Angeles, California, United States, 90069
        • Anthony Mills MD Inc
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, M.D., Inc.
      • Los Angeles, California, United States, 90043
        • OASIS Clinic
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • Sacramento, California, United States, 95841
        • Kaiser Permanente
      • San Diego, California, United States, 92103
        • La Playa Medical Group and Clinical Research
      • San Francisco, California, United States, 94118
        • Kaiser Permanente San Francisco
      • San Francisco, California, United States, 94109
        • Metropolis Medical
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Capital Medical Associates, PC
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physicians Group, P.C
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond, MD
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology & Research Center, LLC
      • Miami, Florida, United States, 33133
        • The Kinder Medical Group
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • IDOCF/ValuhealthMD, LLC
      • Pensacola, Florida, United States, 32504
        • Infectious Diseases Associates of NW FL, P.A.
      • Safety Harbor, Florida, United States, 34695
        • AHF Health Positive Tampa Bay
      • Tampa, Florida, United States, 33614
        • St. Joseph's Comprehensive Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta ID Group
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Division of Infectious Diseases
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Be Well Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • The Kansas City Free Health Clinic
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • I.D. Care Associates PA
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Disease
    • New York
      • Mt. Vernon, New York, United States, 10550
        • Greiger Clinic
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • ID Consultants, P.A.
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Texas
      • Dallas, Texas, United States, 75204
        • Uptown Physicians Group
      • Dallas, Texas, United States, 75219
        • Southwest Infectious Disease Clinical Research, Inc
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Disease Associates
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, United States, 77098
        • Gordon Crofoot MD, PA
      • Houston, Texas, United States, 77401
        • St. Hope Foundation Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form
  • Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit
  • Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 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 therapy showing 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 contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
  • 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
  • Male participants must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be nonheterosexually active, or practice sexual abstinence
  • Age ≥ 18 years

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 to receive 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 than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients 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 participant unsuitable for the study or unable to comply with the dosing requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stribild
Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
Drug: Stribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
ACTIVE_COMPARATOR: PI+RTV+FTC/TDF
Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
Drug: Stribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Drug: PI
PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
Drug: RTV
RTV administered according to prescribing information FTC/TDF administered according to prescribing information
Drug: FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Other Names:
  • Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Time Frame: Week 48
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Time Frame: Baseline; Week 96
Baseline; Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Time Frame: Week 96
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Thai Nguyen-Cleary, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (ESTIMATE)

November 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-236-0115
  • 2011-004483-30 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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