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

HIV Infections Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection in HIV Infected Persons
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Infection

• NCT number: NCT00215839
• Study type: Interventional
• Source: Hepatitis Resource Network
• Status: Active, not recruiting
• Phase: Phase 3