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Interferon

Peginterferon + Ribavirin for Co-infection of Hepatitis C and HIV

Phase 3
Waitlist Available
Led By Douglas Dieterich, MD
Research Sponsored by Hepatitis Resource Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous antiviral treatment with alfa interferon monotherapy or interferon alfa plus ribavirin combination therapy administered for at least 12 weeks with the failure to obtain a sustained virologic response
Compensated liver disease with specific laboratory parameters at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of CHC infection in persons co-infected with HIV who have failed to achieve a sustained virologic response following previous interferon therapy.

Who is the study for?
This trial is for HIV-infected adults with chronic hepatitis C who haven't responded to previous interferon therapy. Participants must be over 18, have a detectable HCV-RNA level, and a liver biopsy showing chronic hepatitis C. They can't join if they've had certain treatments in the last 4 weeks or have advanced liver disease, severe retinopathy, major organ transplants, alcohol/drug abuse within a year, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests Peginterferon a-2a combined with Ribavirin versus Peginterferon alone in those who didn’t respond at week 24 of treatment. The combo is given based on body weight; non-responders at week 24 either continue with lower-dose Peginterferon monotherapy or stop treatment for further evaluation.See study design
What are the potential side effects?
Possible side effects include flu-like symptoms (fever, fatigue), mood changes (depression), blood issues (anemia), injection site reactions, and problems related to long-term use such as thyroid dysfunction and vision changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was treated with interferon for my viral infection but it didn't work.
Select...
My liver is functioning well enough, according to recent tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 virologi
Secondary outcome measures
To evaluate the sustained virological response at post-treatment weeks 4, 12, and 24 as compared to baseline.
To evaluate the virological response at weeks 12 and 24 as compared to baseline values.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheIndustry Sponsor
2,428 Previous Clinical Trials
1,089,054 Total Patients Enrolled
Hepatitis Resource NetworkLead Sponsor
2 Previous Clinical Trials
900 Total Patients Enrolled
Douglas Dieterich, MDPrincipal InvestigatorChair - Hepatitis Resource Network
1 Previous Clinical Trials
125,706 Total Patients Enrolled

Media Library

Peginterferon a-2a (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT00215839 — Phase 3
Chronic Hepatitis C Research Study Groups:
Chronic Hepatitis C Clinical Trial 2023: Peginterferon a-2a Highlights & Side Effects. Trial Name: NCT00215839 — Phase 3
Peginterferon a-2a (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00215839 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research effort interested in elderly volunteers?

"The age group that this study is looking for are individuals who have not yet turned 18 years old."

Answered by AI

Would you say this treatment is considered high-risk?

"This is a Phase 3 trial, which means that while there is data supporting efficacy, there have been multiple rounds of testing to confirm safety. Our team rates the safety at a 3."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Mt. Sinai School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00215839.
All > Autoimmune Hepatitis > Cte
~233 spots leftby Apr 2025
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