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
NCT ID: NCT01475838
Last Updated: 2016-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
438 participants
INTERVENTIONAL
2011-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Stribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
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.
PI
PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
RTV
RTV administered according to prescribing information FTC/TDF administered according to prescribing information
FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Stribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Interventions
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PI
PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
RTV
RTV administered according to prescribing information FTC/TDF administered according to prescribing information
FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Stribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Thai Nguyen-Cleary
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
Barcelona, , Spain
Hospital Germans Trias I Pujol
Barcelona, , Spain
Spectrum Medical Group
Phoenix, Arizona, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
AIDS Healthcare Foundation
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, M.D., Inc.
Los Angeles, California, United States
OASIS Clinic
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, Davis
Sacramento, California, United States
Kaiser Permanente
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Metropolis Medical
San Francisco, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Dupont Circle Physicians Group, P.C
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Gary Richmond, MD
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Idocf/Valuhealthmd, Llc
Orlando, Florida, United States
Infectious Diseases Associates of NW FL, P.A.
Pensacola, Florida, United States
AHF Health Positive Tampa Bay
Safety Harbor, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
Northwestern University Division of Infectious Diseases
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Be Well Medical Center
Berkley, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
The Kansas City Free Health Clinic
Kansas City, Missouri, United States
I.D. Care Associates PA
Hillsborough, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Greiger Clinic
Mount Vernon, New York, United States
ID Consultants, P.A.
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Uptown Physicians Group
Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Gordon Crofoot Md, Pa
Houston, Texas, United States
St. Hope Foundation Inc
Houston, Texas, United States
Innsbruck Medical University
Innsbruck, , Austria
Univ.-Kklinik fuer Innere Medizin III
Salzburg, , Austria
Medical University of Vienna
Vienna, , Austria
Otto-Wagner-Spital
Vienna, , Austria
UCL Saint Luc
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
CHU Sart Tilman
Liège, , Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada
CHU de Besancon, Hopital Saint-Jacques
Besançon, , France
Hôpital de la Croix-Rousse
Lyon, , France
CHU Hôpital Gui de Chauliac
Montpellier, , France
Archet 1 Chu Nice Department of Infectology
Nice, , France
Saint-Louis Hospital
Paris, , France
Hopital Saint Antoine
Paris, , France
Hôpital Bichat-Claude Bernard
Paris, , France
hôpital Tenon
Paris, , France
Maladies Infectieuses Dpt
Paris, , France
Hôpital Haut Lévêque
Pessac, , France
Epimed GmbH
Berlin, , Germany
University of Bonn
Bonn, , Germany
Infektlonsambulanz Unlkllnik Koln
Cologne, , Germany
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
Essen, , Germany
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
Frankfurt, , Germany
ICH Study Center
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
Munich, , Germany
Ospedali Riuniti
Bergamo, , Italy
Hospital General Universitario de Elche
Elche, Alicante, , Spain
Fondazione Centro San Raffaele
Milan, , Italy
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milan, , Italy
Ospedale Luigi Sacco
Milan, , Italy
National Institute for Infectious Diseases "L. Spallanzani"
Rome, , Italy
University of Torino, Dept of Infectious Disease
Torino, , Italy
HHP Hospital de Cascais
Alcabideche, , Portugal
Hospital de Santa Maria-CHLN, EPE
Lisbon, , Portugal
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
Lisbon, , Portugal
Clinical Research Puert Rico
San Juan, , Puerto Rico
University of Puerto Rico School of Medicine
San Juan, , Puerto Rico
Hospital General Universitario Alicante
Alicante, , Spain
Hospital clinic
Barcelona, , Spain
Infectious Diseases Department, Hospital Carlos III
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Geneva University Hospital
Geneva, , Switzerland
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
Zurich, , Switzerland
Zentrum fur Infektionskrankheiten
Zurich, , Switzerland
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Royal Free Hampstead NHS Trust
London, , United Kingdom
Chelsea and Westminster
London, , United Kingdom
Countries
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References
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Arribas JR, Pialoux G, Gathe J, Di Perri G, Reynes J, Tebas P, Nguyen T, Ebrahimi R, White K, Piontkowsky D. Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):581-9. doi: 10.1016/S1473-3099(14)70782-0. Epub 2014 Jun 5.
Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.
Arribas JR, DeJesus E, van Lunzen J, Zurawski C, Doroana M, Towner W, Lazzarin A, Nelson M, McColl D, Andreatta K, Swamy R, Szwarcberg J, Nguyen T. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. HIV Clin Trials. 2017 May;18(3):118-125. doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30.
Gathe J, Arribas JR, Van Lunzen J, Garner W, Speck RM, Bender R, Shreay S, Nguyen T. Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.
Other Identifiers
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2011-004483-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-236-0115
Identifier Type: -
Identifier Source: org_study_id
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