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Completed Phase 2 Interventional

A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)

ClinicalTrials.gov ID: NCT00008463

Public ClinicalTrials.gov record NCT00008463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multicenter, Phase II/III, Open-Label, Controlled, Randomized Trial Evaluating the Efficacy, Safety, and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus (HCV) Infection in Individuals Co-Infected With Human Immunodeficiency Virus-1 (HIV-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.

Study identification

NCT ID
NCT00008463
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2000 (Type not available)
Primary completion
Not listed
Completion
Aug 2006 (Type not available)
Last update posted
Nov 1, 2021

2000 – 2006

United States locations

U.S. sites
24
U.S. states
13
U.S. cities
15
Facility City State ZIP Site status
Ucsd, Avrc Crs San Diego California 92103 —
Ucsf Aids Crs San Francisco California 941104206 —
University of Colorado Hospital CRS Aurora Colorado 80262 —
Univ. of Miami AIDS CRS Miami Florida 331361013 —
The Ponce de Leon Ctr. CRS Atlanta Georgia 30308 —
Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii 96816 —
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana 462025250 —
Indiana Univ. School of Medicine, Wishard Memorial Indianapolis Indiana 46202 —
Methodist Hosp. of Indiana Indianapolis Indiana 46202 —
Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City Iowa 52242 —
Massachusetts General Hospital ACTG CRS Boston Massachusetts 02114 —
Bmc Actg Crs Boston Massachusetts 02118 —
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215 —
Brigham and Women's Hosp. ACTG CRS Boston Massachusetts 02215 —
University of Minnesota, ACTU Minneapolis Minnesota 55455 —
Beth Israel Med. Ctr., ACTU New York New York 10003 —
NY Univ. HIV/AIDS CRS New York New York 10016 —
Mt. Sinai Med. Ctr. A0404 CRS New York New York 10029 —
HIV Prevention & Treatment CRS New York New York — —
AIDS Care CRS Rochester New York 14642 —
Univ. of Rochester ACTG CRS Rochester New York 14642 —
Univ. of Cincinnati CRS Cincinnati Ohio 452670405 —
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS Philadelphia Pennsylvania 19104 —
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic Dallas Texas 75390 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00008463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2021 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00008463 live on ClinicalTrials.gov.

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