CompletedPhase 4

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

United States138 participantsStarted 2011-05-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48

Timeframe: 48 weeks

Trial details

NCT IDNCT01327547

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-23

Results submitted2014-04-09

View on ClinicalTrials.gov More HIV Coinfection trials