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A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

Primary Purpose

HIV Coinfection

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Maraviroc
Placebo
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Coinfection focused on measuring HIV coinfection, maraviroc, CCR5 blocker, entry inhibitor, liver disease, viral hepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Office of Dr. Franco Antonio Felizarta, M.D.
  • AIDS Research Alliance
  • Alameda Health System - Highland Hospital
  • University of California Davis Research
  • University of California
  • University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)
  • University of California, San Francisco - Mt. Zion Hospital
  • Community AIDS Resource Inc dba Care Resource
  • University of South Florida Health - HIV Clinical Research Unit
  • Rowan Tree Medical, P.A.
  • Georgia Regents Medical Center
  • University of Iowa Hospitals and Clinics
  • Henry Ford Hospital
  • Saint Michael's Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Mount Sinai Faculty Practice Associates
  • The Mount Sinai Hospital
  • New York Medical College
  • I.D. Consultants, P.A.
  • Kaiser Permanente Sunnybrook Medical Office
  • Kaiser Permanente Northwest
  • Southwest Infectious Disease Clinical Research Inc.
  • University of Texas Southwestern Medical Center at Dallas
  • University Health Care Center Downtown
  • Fakultni nemocnice Brno
  • Hopital de la Croix Rousse
  • Centre Hospitalier Cochin Saint Vincent de Paul
  • Hopital Tenon, Service des Maladies Infectieuses
  • EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
  • Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
  • ifi - Studien und Projekte GmbH
  • Universitaetsklinikum Hamburg-Eppendorf
  • Klinikum der Universitaet zu Koeln
  • Ludwig-Maximilians-Universitaet
  • Egyesített Szent István és Szent László Kórház Rendelőintézet
  • EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
  • Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy
  • SPZOZ Wojewodzki Szpital Zakazny
  • Ararat Research Center
  • Farmacia UPR-CTU
  • University of Puerto Rico - School of Medicine
  • Hospital Universitari Vall dHebron
  • Hospital Reina Sofia Hospital Provincial
  • Hospital Carlos Iii
  • Hospital Nuestra Señora de Valme
  • Consorcio Hospital General Universitario de Valencia
  • Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust
  • St Stephen's AIDS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1.0

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144
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 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities
Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L
Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L
Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Number of Participants With Hy's Law Abnormalities Through Week 144
Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144
The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the "virology-first principle" and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144
Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144
Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.
Plasma samples were used to determine markers of immune activation namely CRP.
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144
Plasma samples were used to determine markers of immune activation namely D-Dimer.
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144
Plasma samples were used to determine markers of immune activation namely TGF beta.
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144
Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144
Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144
The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144
Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.
Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144
Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.
Summary of Estimated Maraviroc PK Parameters
Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.
Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48
The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.

Full Information

First Posted
March 22, 2011
Last Updated
November 2, 2017
Sponsor
ViiV Healthcare
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01327547
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 18, 2011 (Actual)
Primary Completion Date
April 23, 2013 (Actual)
Study Completion Date
March 24, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Coinfection
Keywords
HIV coinfection, maraviroc, CCR5 blocker, entry inhibitor, liver disease, viral hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry, Celsentri
Intervention Description
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Primary Outcome Measure Information:
Title
Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144
Description
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 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Time Frame
Week 96 and 144
Title
Time to Development of Grade 3 and Grade 4 ALT Abnormalities
Description
Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.
Time Frame
144 weeks
Title
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L
Description
Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time Frame
144 weeks
Title
Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L
Description
Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time Frame
144 weeks
Title
Number of Participants With Hy's Law Abnormalities Through Week 144
Description
Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN
Time Frame
144 weeks
Title
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144
Description
The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the "virology-first principle" and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).
Time Frame
Week 48, 96 and 144
Title
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144
Description
Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame
Week 48, 96 and 144
Title
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144
Description
Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.
Description
Plasma samples were used to determine markers of immune activation namely CRP.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144
Description
Plasma samples were used to determine markers of immune activation namely D-Dimer.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144
Description
Plasma samples were used to determine markers of immune activation namely TGF beta.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144
Description
Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144
Description
Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144
Description
The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.
Time Frame
48, 96 and 144 weeks
Title
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144
Description
Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.
Time Frame
48, 96 and 144 weeks
Title
Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144
Description
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Time Frame
Baseline and Week 144
Title
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144
Description
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Time Frame
Week 144
Title
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144
Description
Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.
Time Frame
144 Weeks
Title
Summary of Estimated Maraviroc PK Parameters
Description
Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.
Time Frame
Week 48
Title
Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48
Description
The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Office of Dr. Franco Antonio Felizarta, M.D.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
AIDS Research Alliance
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Alameda Health System - Highland Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
University of California Davis Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95811
Country
United States
Facility Name
University of California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of California, San Francisco - Mt. Zion Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Community AIDS Resource Inc dba Care Resource
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
University of South Florida Health - HIV Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Rowan Tree Medical, P.A.
City
Wilton Manors
State/Province
Florida
ZIP/Postal Code
33305
Country
United States
Facility Name
Georgia Regents Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Faculty Practice Associates
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
I.D. Consultants, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Kaiser Permanente Sunnybrook Medical Office
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Southwest Infectious Disease Clinical Research Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University Health Care Center Downtown
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Hopital de la Croix Rousse
City
Lyon cedex 4
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Hospitalier Cochin Saint Vincent de Paul
City
Paris CEDEX 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hopital Tenon, Service des Maladies Infectieuses
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
ifi - Studien und Projekte GmbH
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum der Universitaet zu Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Ludwig-Maximilians-Universitaet
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Egyesített Szent István és Szent László Kórház Rendelőintézet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Zakazny
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Ararat Research Center
City
Ponce
ZIP/Postal Code
00717-1567
Country
Puerto Rico
Facility Name
Farmacia UPR-CTU
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
University of Puerto Rico - School of Medicine
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Hospital Universitari Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Reina Sofia Hospital Provincial
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Carlos Iii
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Hospital Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St Stephen's AIDS Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27924779
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.
Results Reference
derived
PubMed Identifier
25923596
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. Erratum In: HIV Clin Trials. 2015 Nov;16(6):236-8.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001098&StudyName=A%20Study%20Of%20Maraviroc%20In%20HIV%20Co-Infected%20Subjects%20With%20Hepatitis%20C%20And/Or%20Hepatitis%20B
Description
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Learn more about this trial

A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

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