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)
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.
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
Conditions
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
- Oct 31, 2000
- Primary completion
- Not listed
- Completion
- Jul 31, 2006
- Last update posted
- Oct 31, 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 Oct 31, 2021 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00008463 live on ClinicalTrials.gov.