Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
NCT ID: NCT01345630
Last Updated: 2016-01-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
813 participants
INTERVENTIONAL
2011-09-30
2014-01-31
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
DOUBLE
Study Groups
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Maraviroc
Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.
darunavir/ritonavir 800/100 mg
darunavir/ritonavir 800/100 mg
placebo for maraviroc
placebo for maraviroc
Emtricitabine/tenofovir
Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
placebo for emtricitabine/tenofovir
placebo for emtricitabine/tenofovir
Interventions
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Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.
Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
darunavir/ritonavir 800/100 mg
darunavir/ritonavir 800/100 mg
placebo for emtricitabine/tenofovir
placebo for emtricitabine/tenofovir
placebo for maraviroc
placebo for maraviroc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4 count equal to or greater than 100 cells/mm3 at Screening.
* Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.
Exclusion Criteria
* Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
* CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama, United States
Health Services Center
Hobson City, Alabama, United States
Kaiser Permanente
Hayward, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Dr. Anthony Mills, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
University of California Davis Research
Sacramento, California, United States
TICON I Research Clinic (DEXA Scan only)
Sacramento, California, United States
Kaiser Hospital Sacramento
Sacramento, California, United States
Synarc Inc.
San Francisco, California, United States
Investigational Drugs Pharmacy
San Francisco, California, United States
Kaiser Permanente - Clinical Trials Unit
San Francisco, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Kaiser Permanente
Union City, California, United States
University of Colorado Denver - University of Colorado Hospital
Aurora, Colorado, United States
Kaiser Permanente of Colorado
Denver, Colorado, United States
Yale - New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Circle CARE Center
Norwalk, Connecticut, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Broward Health - Comprehensive Care Center
Fort Lauderdale, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
UMHC/Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Community AIDS Resource Inc dba Care Resource
Miami, Florida, United States
Miami Research Associates
Miami, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
Infectious Diseases Associates of Northwest Florida, PA
Pensacola, Florida, United States
St. Joseph's Hospital Diagnostic Center
Tampa, Florida, United States
University of South Florida Health-HIV Clinical Research Unit
Tampa, Florida, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States
Osteoporosis Care Center
Tampa, Florida, United States
Quest Diagnostic Laboratory
Tampa, Florida, United States
Rowan Tree Medical, PA
Wilton Manors, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
DeKalb Medical Diagnostic Breast Center
Decatur, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Northwestern University/NMH
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Howard Brown Health Center
Chicago, Illinois, United States
University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
Iowa City, Iowa, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States
Be Well Medical Center, PC
Berkley, Michigan, United States
University Physicians Group
Detroit, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
East Lansing, Michigan, United States
Biomedical and Health Institutional Review Board
East Lansing, Michigan, United States
Ingham County Health Department
Lansing, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Kansas City Free Health Clinic
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Brandywine Common
Neptune City, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York, United States
AIDS Community Research Initiative of America (ACRIA)
New York, New York, United States
Research Across America
New York, New York, United States
Dr. Howard A. Grossman, M.D.
New York, New York, United States
AIDS Care
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
I.D. Consultants, P.A.
Charlotte, North Carolina, United States
(DEXA Scan Facility) East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States
East Carolina University Division of Infectious Diseases
Greenville, North Carolina, United States
University of Cincinnati - Department of Internal Medicine
Cincinnati, Ohio, United States
The University of Toledo Medical Center
Toledo, Ohio, United States
Central Texas Clinical Research
Austin, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
The Office of Dr. Gordon E. Crofoot, M.D., PA
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
East Sydney Doctors
Darlinghurst, New South Wales, Australia
Holdsworth House General Practice
Darlinghurst, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia
Brisbane Sexual Health and HIV Service
Brisbane, Queensland, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, Australia
Clinical Research Unit, Infectious Diseases
Melbourne, Victoria, Australia
AKH Wien Universitaetsklinik fuer Dermatologie
Vienna, , Austria
Instituut voor Tropische Geneeskunde
Antwerp, , Belgium
C.H.U. St-Pierre
Brussels, , Belgium
Hôpital Universitaire Erasme
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
C.H.U. Sart-Tilman
Liège, , Belgium
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
The Ottawa Hospital-Riverside Campus
Ottawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Maple Leaf Research / Maple Leaf Medical Clinic
Toronto, Ontario, Canada
University Health Network / Toronto General Hospital
Toronto, Ontario, Canada
Clinique Medicale L'Actuel
Montreal, Quebec, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Hvidovre Hospital, Infektionsmedicinsk afd.
Hvidovre, , Denmark
Rigshospitalet, Epidemiklinikken
Koebenhavn OE, , Denmark
Odense Universitetshospital
Odense, , Denmark
Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs
Helsinki, , Finland
CHR d'Orleans la Source
Orléans, Cedex 02, France
Hopital Saint Antoine
Paris, Cedex 12, France
Hopital Bichat
Paris, Cedex 18, France
Hopital Saint-andre
Bordeaux, France, France
Hopital Henri Mondor
Créteil, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
Hopital de la Croix Rousse
Lyon, , France
Hopital Gui de Chauliac
Montpellier, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
Hôpital de la Pitié Salpétrière
Paris, , France
Hopital Tenon, Service des Maladies Infectieuses
Paris, , France
Hopital Saint-Louis
Paris, , France
Nouvel Hopital Civil
Strasbourg, , France
Centre Hospitalier de Tourcoing
Tourcoing, , France
Praxis Christiane Cordes
Berlin, , Germany
Studiengesellschaft mbH Gubener 37
Berlin, , Germany
EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Berlin, , Germany
Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
Bonn, , Germany
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
Cologne, , Germany
Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt am Main, , Germany
InfektioResearch GmbH & Co. KG
Frankfurt am Main, , Germany
ifi - Studien und Projekte GmbH
Hamburg, , Germany
ICH - Study - Center GmbH & Co. KG
Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
MUC Research Group GbR
München, , Germany
Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt
München, , Germany
Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
Budapest, , Hungary
Ospedale San Raffaele
Milan, , Italy
University Medical Center Utrecht
Utrecht, , Netherlands
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza
Bydgoszcz, , Poland
SPZOZ Wojewodzki Szpital Zakazny
Warsaw, , Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, , Poland
Hospital Prof. Doutor Fernando Fonseca E.P.E.
Amadora, Portugal, Portugal
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
Lisbon, , Portugal
Hospital Sta. Maria
Lisbon, , Portugal
Hospital São João
Porto, , Portugal
Innovative Care PSC
Bayamón, PR, Puerto Rico
Ararat Research Center
Ponce, PR, Puerto Rico
Medical Center University Hospital
Rio Piedras, PR, Puerto Rico
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico
HOPE Clinical Research
San Juan, PR, Puerto Rico
University of Puerto Rico Medical Sciences Campus
Rio Piedras, , Puerto Rico
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Reina Sofia - Hospital Provincial
Córdoba, Cordoba, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario de La Paz
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, Spain
SU Ostra sjukhuset, Infektionsmottagningen
Gothenburg, , Sweden
Skanes Universitetssjukhus
Malmo, , Sweden
Sodersjukhuset, Venhalsan
Stockholm, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Universitaetsspital Basel Infektiologie und Spitalhygiene
Basel, , Switzerland
Inselspital Universitaetsklinik fuer Infektiologie
Bern, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Dept of Sexual Health & HIV Medicine
Birmingham, , United Kingdom
HIV Research Department, Elton John Centre
Brighton, , United Kingdom
Regional Infectious Diseases Unit
Edinburgh, , United Kingdom
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,
London, , United Kingdom
Ian Charleson Day Centre, Royal Free Hospital
London, , United Kingdom
Queen Elizabeth Hospital
London, , United Kingdom
St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Centre for Sexual Health & HIV Research, University College London
London, , United Kingdom
Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals
Manchester, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-021785-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4001095
Identifier Type: -
Identifier Source: org_study_id
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