NCT00215891

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

Completed Phase 3 Last updated 24 October 2005

What this trial tests

Phase 3 trial testing PEG-Interferon a-2b + Ribavirin in Chronic Hepatitis C Infection in HIV-Infected Persons in 300 participants. Completed.

Quick facts

Lead sponsor	Hepatitis Resource Network
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Sites	1 location across United States

Drugs / interventions tested

• PEG-Interferon a-2b + Ribavirin — full drug profile →

Conditions studied

• Chronic Hepatitis C Infection in HIV-Infected Persons — all drugs for Chronic Hepatitis C Infection in HIV-Infected Persons →
• HIV Infections — all drugs for HIV Infections →

Sponsor

Hepatitis Resource Network

Who can join

18 and older, any sex, with Chronic Hepatitis C Infection in HIV-Infected Persons or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.