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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2000-11 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00008463
The ClinicalTrials.gov registry entry for NCT00008463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00008463 reports 0 study locations.
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.
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