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PEG-Interferon a-2b + Ribavirin for Treatment of Chronic HRN 005 Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon

NCT00215891 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2005-10-25

No results posted yet for this study

Summary

Objectives:

Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).

Secondary

* To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
* To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24

Study Design:

All qualifying patients will enter the treatment phase and be dosed as follows:

Peginterferon a-2b 1.5mg/kg 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 and \< 105 kg
* 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg

At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:

* Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment.
* Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment.

Study Population:

300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy.

Dosage and Administration:

Peginterferon a-2b 1.5mg/kg 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 and \< 105 kg
* 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg

Efficacy Evaluations:

Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b 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

PEG-Interferon a-2b + Ribavirin

Sponsors & Collaborators

  • Integrated Therapeutics Group

    collaborator INDUSTRY

  • Subsidiary of Schering-Plough

    collaborator UNKNOWN

  • Hepatitis Resource Network

    lead OTHER

Principal Investigators

  • Mark Sulkowski, MD · 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

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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 NCT00215891 on ClinicalTrials.gov