NCT00687544

Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

Conditions

• Hepatitis C, Chronic
• Hepacivirus
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b (SCH 054031)	Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.
DRUG	Ribavirin (SCH 018908)	Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is \<65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is \>85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-05-30
• Last updated: 2017-04-06
• Results posted: 2012-01-30