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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

NCT00215839 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-10-25

No results posted yet for this study

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

DRUG

Peginterferon a-2a plus Ribavirin

Sponsors & Collaborators

Principal Investigators

  • Douglas Dieterich, MD · Chair - Hepatitis Resource Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215839 on ClinicalTrials.gov