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NCT00078403 · ClinicalTrials.gov registry record · Phase 2
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People 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
- 333
- Enrollment target
NCT00078403: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00078403 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 333 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078403, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 333 participants
- Enrollment target
Study Summary
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
Primary Outcome
SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2004-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00078403 record still lists
NCT00078403 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00078403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078403 about?
NCT00078403 is a clinical study titled "Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)". Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected wit...
What is the current status of trial NCT00078403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 333 participants. The study started on 2004-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00078403?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00078403?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00078403's enrollment target sits among peer trials
333 144th of 2000 higher than 1,857 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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