A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus
2 other identifiers
interventional
138
9 countries
48
Brief Summary
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2011
Longer than P75 for phase_4
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedStudy Start
First participant enrolled
May 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2013
CompletedResults Posted
Study results publicly available
November 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2015
CompletedDecember 6, 2017
November 1, 2017
1.9 years
March 22, 2011
April 9, 2014
November 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as \>5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or \>3.5x baseline for participants whose baseline ALT \>ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
48 weeks
Secondary Outcomes (20)
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144
Week 96 and 144
Time to Development of Grade 3 and Grade 4 ALT Abnormalities
144 weeks
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L
144 weeks
Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L
144 weeks
Number of Participants With Hy's Law Abnormalities Through Week 144
144 weeks
- +15 more secondary outcomes
Study Arms (2)
1.0
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Eligibility Criteria
You may qualify if:
- HIV coinfected with HCV and/or HBV.
- 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.
You may not qualify if:
- Currently receiving maraviroc.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Pfizercollaborator
Study Sites (48)
The Office of Dr. Franco Antonio Felizarta, M.D.
Bakersfield, California, 93301, United States
AIDS Research Alliance
Los Angeles, California, 90015, United States
Alameda Health System - Highland Hospital
Oakland, California, 94602, United States
University of California Davis Research
Sacramento, California, 95811, United States
University of California
Sacramento, California, 95817, United States
University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)
San Francisco, California, 94110, United States
University of California, San Francisco - Mt. Zion Hospital
San Francisco, California, 94115, United States
Community AIDS Resource Inc dba Care Resource
Miami, Florida, 33137, United States
University of South Florida Health - HIV Clinical Research Unit
Tampa, Florida, 33602, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, 33305, United States
Georgia Regents Medical Center
Augusta, Georgia, 30912, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Mount Sinai Faculty Practice Associates
New York, New York, 10029, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
New York Medical College
Valhalla, New York, 10595, United States
I.D. Consultants, P.A.
Charlotte, North Carolina, 28209, United States
Kaiser Permanente Sunnybrook Medical Office
Clackamas, Oregon, 97015, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Southwest Infectious Disease Clinical Research Inc.
Dallas, Texas, 75219, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University Health Care Center Downtown
San Antonio, Texas, 78207, United States
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Hopital de la Croix Rousse
Lyon, 69317, France
Hopital Tenon, Service des Maladies Infectieuses
Paris, 75020, France
Centre Hospitalier Cochin Saint Vincent de Paul
Paris, 75679, France
EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Berlin, 12157, Germany
Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
Bonn, 53127, Germany
Klinikum der Universitaet zu Koeln
Cologne, 50937, Germany
ifi - Studien und Projekte GmbH
Hamburg, 20099, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Ludwig-Maximilians-Universitaet
München, 80336, Germany
Egyesített Szent István és Szent László Kórház Rendelőintézet
Budapest, 1097, Hungary
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, Lower Silesian Voivodeship, 50-220, Poland
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy
Bydgoszcz, 85-030, Poland
SPZOZ Wojewodzki Szpital Zakazny
Warsaw, 01-201, Poland
Farmacia UPR-CTU
San Juan, PR, 00935, Puerto Rico
Ararat Research Center
Ponce, 00717-1567, Puerto Rico
University of Puerto Rico - School of Medicine
San Juan, 00935, Puerto Rico
Hospital Universitari Vall dHebron
Barcelona, 08035, Spain
Hospital Reina Sofia Hospital Provincial
Córdoba, 14004, Spain
Hospital Carlos Iii
Madrid, 28029, Spain
Hospital Nuestra Señora de Valme
Seville, 41014, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust
London, SE1 7EH, United Kingdom
St Stephen's AIDS Trust
London, SW10 9NH, United Kingdom
Related Publications (2)
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.
PMID: 27924779DERIVEDRockstroh 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.
PMID: 25923596DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The median time to development of Grade 3 and 4 ALT abnormalities was not estimable due to too few events reported under each treatment group.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
April 1, 2011
Study Start
May 18, 2011
Primary Completion
April 23, 2013
Study Completion
March 24, 2015
Last Updated
December 6, 2017
Results First Posted
November 14, 2014
Record last verified: 2017-11