A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
NCT ID: NCT01327547
Last Updated: 2017-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
138 participants
INTERVENTIONAL
2011-05-18
2015-03-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1.0
Maraviroc
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
2
Placebo
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Interventions
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Maraviroc
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Placebo
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
* Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.
Exclusion Criteria
* Active opportunistic infections.
* ALT and/or AST \>5x upper limit of normal.
* Direct bilirubin \>1.5x upper limit of normal.
* Severe or decompensated liver disease.
* Liver disease unrelated to viral hepatitis infection.
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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The Office of Dr. Franco Antonio Felizarta, M.D.
Bakersfield, California, United States
AIDS Research Alliance
Los Angeles, California, United States
Alameda Health System - Highland Hospital
Oakland, California, United States
University of California Davis Research
Sacramento, California, United States
University of California
Sacramento, California, United States
University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)
San Francisco, California, United States
University of California, San Francisco - Mt. Zion Hospital
San Francisco, California, United States
Community AIDS Resource Inc dba Care Resource
Miami, Florida, United States
University of South Florida Health - HIV Clinical Research Unit
Tampa, Florida, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, United States
Georgia Regents Medical Center
Augusta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Mount Sinai Faculty Practice Associates
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
New York Medical College
Valhalla, New York, United States
I.D. Consultants, P.A.
Charlotte, North Carolina, United States
Kaiser Permanente Sunnybrook Medical Office
Clackamas, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Southwest Infectious Disease Clinical Research Inc.
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University Health Care Center Downtown
San Antonio, Texas, United States
Fakultni nemocnice Brno
Brno, , Czechia
Hopital de la Croix Rousse
Lyon, , France
Hopital Tenon, Service des Maladies Infectieuses
Paris, , France
Centre Hospitalier Cochin Saint Vincent de Paul
Paris, , France
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
Cologne, , Germany
ifi - Studien und Projekte GmbH
Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Ludwig-Maximilians-Universitaet
München, , Germany
Egyesített Szent István és Szent László Kórház Rendelőintézet
Budapest, , Hungary
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, Lower Silesian Voivodeship, Poland
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy
Bydgoszcz, , Poland
SPZOZ Wojewodzki Szpital Zakazny
Warsaw, , Poland
Farmacia UPR-CTU
San Juan, PR, Puerto Rico
Ararat Research Center
Ponce, , Puerto Rico
University of Puerto Rico - School of Medicine
San Juan, , Puerto Rico
Hospital Universitari Vall dHebron
Barcelona, , Spain
Hospital Reina Sofia Hospital Provincial
Córdoba, , Spain
Hospital Carlos Iii
Madrid, , Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust
London, , United Kingdom
St Stephen's AIDS Trust
London, , United Kingdom
Countries
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References
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Rockstroh JK, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J. Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.
Rockstroh JK, Soriano V, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA. Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-021994-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4001098
Identifier Type: -
Identifier Source: org_study_id