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NCT00008463 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
132
Enrollment target

NCT00008463: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00008463 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00008463, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
132 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Ribavirin
  • DRUG Peginterferon alfa-2a
  • DRUG Interferon alfa-2a

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2000-11
Est. Completion 2006-08
Phase Phase 2

What the finished NCT00008463 record still lists

NCT00008463 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.

NCT00008463 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00008463 about?

NCT00008463 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT00008463?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2000-11. Estimated completion is 2006-08.

What interventions are being tested in trial NCT00008463?

The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), Interferon alfa-2a (DRUG).

Who is sponsoring clinical trial NCT00008463?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00008463's enrollment target sits among peer trials

132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00008463, the US trial registry maintained by the National Library of Medicine. NCT00008463 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.