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

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 Hepatitis C Hepatitis B Hepatotoxicity	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:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis B Hepatitis C

Drug Information available for: Maraviroc Hepatitis A Vaccines

U.S. FDA Resources

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 ]

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
Estimated 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 44 Study Locations

Sponsors and Collaborators

ViiV Healthcare

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	February 14, 2013
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 February 28, 2013