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

• Status: Completed
• Trial end date: 2015-03-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Anti-Retroviral Agents; Maraviroc

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.