Clinical trial NCT01327547: A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Coinfection
Keywords: HIV coinfection
maraviroc
CCR5 blocker
entry inhibitor
liver disease
viral hepatitis
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-04-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
timeFrame: 48 weeks
Secondary outcomes:
measure: Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144
timeFrame: Week 96 and 144
measure: Time to Development of Grade 3 and Grade 4 ALT Abnormalities
timeFrame: 144 weeks
measure: Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L
timeFrame: 144 weeks
measure: Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L
timeFrame: 144 weeks
measure: Number of Participants With Hy's Law Abnormalities Through Week 144
timeFrame: 144 weeks
measure: Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144
timeFrame: Week 48, 96 and 144
measure: Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144
timeFrame: Week 48, 96 and 144
measure: Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144
timeFrame: 48, 96 and 144 weeks
measure: Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144
timeFrame: Baseline and Week 144
measure: Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144
timeFrame: Week 144
measure: Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144
timeFrame: 144 Weeks
measure: Summary of Estimated Maraviroc PK Parameters
timeFrame: Week 48
measure: Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48
timeFrame: Week 48
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: The Office of Dr. Franco Antonio Felizarta, M.D.
state: California
city: Los Angeles
country: United States
facility: AIDS Research Alliance
state: California
city: Oakland
country: United States
facility: Alameda Health System - Highland Hospital
state: California
city: Sacramento
country: United States
facility: University of California Davis Research
state: California
city: Sacramento
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Mt. Zion Hospital
state: California
city: Miami
country: United States
facility: Community AIDS Resource Inc dba Care Resource
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health - HIV Clinical Research Unit
state: Florida
city: Wilton Manors
country: United States
facility: Rowan Tree Medical, P.A.
state: Florida
city: Augusta
country: United States
facility: Georgia Regents Medical Center
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Mount Sinai Faculty Practice Associates
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Charlotte
country: United States
facility: I.D. Consultants, P.A.
state: North Carolina
city: Clackamas
country: United States
facility: Kaiser Permanente Sunnybrook Medical Office
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Dallas
country: United States
facility: Southwest Infectious Disease Clinical Research Inc.
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: San Antonio
country: United States
facility: University Health Care Center Downtown
state: Texas
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Lyon cedex 4
country: France
facility: Hopital de la Croix Rousse
city: Paris CEDEX 14
country: France
facility: Centre Hospitalier Cochin Saint Vincent de Paul
city: Paris
country: France
facility: Hopital Tenon, Service des Maladies Infectieuses
city: Berlin
country: Germany
facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
city: Hamburg
country: Germany
facility: ifi - Studien und Projekte GmbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Koeln
country: Germany
facility: Klinikum der Universitaet zu Koeln
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház Rendelőintézet
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy
city: Warszawa
country: Poland
facility: SPZOZ Wojewodzki Szpital Zakazny
city: Ponce
country: Puerto Rico
facility: Ararat Research Center
city: San Juan
country: Puerto Rico
facility: Farmacia UPR-CTU
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - School of Medicine
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron
city: Cordoba
country: Spain
facility: Hospital Reina Sofia Hospital Provincial
city: Madrid
country: Spain
facility: Hospital Carlos Iii
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: London
country: United Kingdom
facility: Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: St Stephen's AIDS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.