NCT00215839

HRN 004- Peginterferon a-2a Plus Ribavirin for Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon Therapy

A Multi-Center, Randomized, Open-Label, Phase IIIb Study Investigating the Safety and Efficacy of Peginterferon a-2a Plus Ribavirin for the Treatment of Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Hepatitis Resource Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objectives: Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic response following previous interferon therapy. Secondary * To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values. * To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4, 12, and 24 as compared to baseline. * To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values. * To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy. * To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease. Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks. * Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks. * Group B: No CHC therapy for 72 weeks All patients entering the study are required to have a baseline liver biopsy (within 18 months of study entry). Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial. Study Population: 100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy. Dosage and Administration: Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly. Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2a and Ribavirin dosages will be obtained. Safety Evaluations: * Assessment of laboratory evaluations * vital signs * incidence and severity of adverse experiences * dose adjustments * premature withdrawal for safety reasons * progression of disease as measured by HCV viral load * AIDS defining events

Conditions

• Chronic Hepatitis C Infection in HIV Infected Persons
• HIV Infections

Interventions

Type	Name	Description
DRUG	Peginterferon a-2a plus Ribavirin

Timeline

• First posted: 2005-09-22
• Last updated: 2005-10-25

Locations

1 site across 1 country: United States