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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01327547
First received: March 22, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

March 22, 2011
May 7, 2013
April 2011
April 2013   (final data collection date for primary outcome measure)
Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for subjects whose baseline ALT ≤ULN, or or >3.5x baseline for subjects whose baseline ALT >ULN. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
At Week 48 in the maraviroc arm versus the placebo arm.
Complete list of historical versions of study NCT01327547 on ClinicalTrials.gov Archive Site
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events and laboratory abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fibrosis score (Ishak) in liver biopsy samples at Week 144 (liver biopsy substudy) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Population pharmacokinetic analysis of time versus plasma concentration of maraviroc. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Exploratory exposure-response relationship, if any, between maraviroc PK and liver fibrosis biomarkers, any changes from baseline that may be observed in AST and ALT measurements or other laboratory measurements. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Health economic impact, as measured by the utilization of hepatic fibrosis and cirrhosis-related inpatient and outpatient services and associated costs of care. [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT >=100 IU/L [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with plasma HIV-1 RNA concentration <40 copies/mL [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ and CD8+ cell counts [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events and laboratory abnormalities [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in markers of immune activation (CD38 expression on CD4 and CD8 cells, C-reactive protein, D-dimer, transforming growth factor-beta [TGF-beta]) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HCV RNA [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HBV DNA [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Enhanced Liver Fibrosis (ELF) test [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the hepatic elastography (FibroscanTM) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fibrosis score (Ishak) in liver biopsy samples at Week 144 (liver biopsy substudy) [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Population pharmacokinetic analysis of time versus plasma concentration of maraviroc [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Exploratory exposure-response relationship, if any, between maraviroc PK and liver fibrosis biomarkers, any changes from baseline that may be observed in AST and ALT measurements or other laboratory measurements. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Health economic impact, as measured by the utilization of hepatic fibrosis and cirrhosis-related inpatient and outpatient services and associated costs of care. [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Coinfection
  • Hepatitis C
  • Hepatitis B
  • Hepatotoxicity
  • Drug: Maraviroc
    150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
    Other Name: Selzentry, Celsentri
  • Drug: Placebo
    150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
  • Experimental: 1.0
    Intervention: Drug: Maraviroc
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
March 2015
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   Germany,   Hungary,   Poland,   Puerto Rico,   Spain,   United Kingdom
 
NCT01327547
A4001098
Yes
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP