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: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HIV Coinfection
Drug: Maraviroc
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of subjects with Grade 3 and Grade 4 ALT abnormalities. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    abnormalities defined as >5x upper limit of normal (ULN) for subjects whose baseline ALT ≤ULN, or >3.5x baseline for subjects whose baseline ALT >ULN, at Week 48 in the maraviroc arm versus the placebo arm


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: March 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 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
Placebo Comparator: 2 Drug: Placebo
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327547

  Show 45 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01327547     History of Changes
Other Study ID Numbers: A4001098
Study First Received: March 22, 2011
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV coinfection
maraviroc
CCR5 blocker
entry inhibitor
liver disease
viral hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014