Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT ID: NCT01495702
Last Updated: 2016-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2011-12-31
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® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
NNRTI+FTC/TDF
Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
NNRTI
NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.
FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Interventions
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NNRTI
NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.
FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; 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 stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.
* Be on the first or second antiretroviral regimen with 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
* Adequate hematologic function
* Serum amylase ≤ 5 × ULN
* Estimated glomerular filtration rate ≥ 70 mL/min
* Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants 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 protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.
* Age ≥ 18 years
Exclusion Criteria
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Receiving drug treatment for hepatitis C, or those 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 (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.
* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* 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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Damian McColl
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Spectrum Medical Group
Phoenix, Arizona, United States
AHF Research Center
Beverly Hills, California, United States
Pacific Oak Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
OASIS Clinic
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Alameda County Medical Center
Oakland, California, United States
Kaiser Permanente Medical Group
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, California, United States
Dupont Circle Physicians Group, P.C.
Washington D.C., District of Columbia, United States
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, United States
Gary Richmond MD, PA, Inc
Fort Lauderdale, Florida, United States
Midway Immunology and Research
Ft. Pierce, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
ValuHealth MD, LLC
Orlando, Florida, United States
Infectious Diseases Associates of Northwest Florida
Pensacola, Florida, United States
Health Positive
Safety Harbor, Florida, United States
Atlanta ID Group, PC
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Be Well Medical Center
Berkley, Michigan, United States
HIV Program Hennepin County Medical Center
Minneapolis, Minnesota, United States
The Kansas City Free Health Clinic
Kansas City, Missouri, United States
ID Care
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
Aaron Diamond AIDS Research Center
New York, New York, United States
ID Consultants, P.A.
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Clinical Researach Inc
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts PA
Houston, Texas, United States
Gordon E. Crofoot MD, PA
Houston, Texas, United States
Clinical Alliance for Research & Education - Infectious Disease
Annandale, Virginia, United States
Holdsworth House Medical Practice
Darlinghurst, , Australia
Prahran Market Clinic
South Yarra, , Australia
East Sydney Doctors
Sydney, , Australia
Medical University of Vienna
Vienna, , Austria
Otto Wagner Spital
Vienna, , Austria
SEAMEO Regional Centre for Tropical Medicine
Antwerp, , Belgium
Hôpitaux IRIS Sud
Brussels, , Belgium
University Hospital of Leuven
Leuven, , Belgium
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada
CHU de Besancon - Hopital Saint-Jacques
Besançon, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hopital Saint Louis
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
Hopital Saint Antoine
Paris, , France
EPIMED GmbH
Berlin, , Germany
MIB Dienstleistung GmbH
Berlin, , Germany
Medizinische Universitätsklinik
Bonn, , Germany
Infektiologikum
Frankfurt, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
ICH Study Center
Hamburg, , Germany
MUC Research GmbH
München, , Germany
Azienda Ospedaliera Ospedale di Circolo Busto Arsizio
Busto Arsizio/Varese, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, , Italy
Policlinico Universitario Agostino Gemelli
Rome, , Italy
Hospital de Santa Maria - CHLN EPE
Lisbon, , Portugal
Clinical Research Puerto Rico Inc
San Juan, Puerto Rica, Puerto Rico
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital La Fe de Valencia
Valencia, , Spain
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Homerton University Hospital
London, , United Kingdom
South London Healthcare NHS Trust
London, , United Kingdom
St. Thomas' Hospital
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Countries
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References
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Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.
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.
Other Identifiers
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2011-004963-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-236-0121
Identifier Type: -
Identifier Source: org_study_id
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