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

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.

Timeline

Start

2011-05-18

Primary completion

2013-04-23

Completion

2015-03-24

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Maraviroc vs Placebo; p = 0.4598; Difference in proportion -0.0020 (95% CI -0.0417 to 0.0376); Cochran-Mantel-Haenszel NCT01327547 ↗

Publications

• Rockstroh JK, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J. Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.
• Rockstroh JK, Soriano V, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA. Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011.

Drugs

Indications