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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Infection
Parasitic Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014