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NCT01443923 · ClinicalTrials.gov registry record · Phase 4
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT01443923 is a Phase 4 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 4 participants.
The verdict
NCT01443923, a Phase 4 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: \- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV. Objectives: \- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections. Eligibility: * Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV * Half of the study participants will also have HIV infection. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests. * Participants will also have heart and liver function tests, and answer questions about mood and depression. * Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly. * Two weeks after starting treatment, participants will have blood tests to study the treatment. * Four weeks after starting treatment, participants will start taking boceprevir three times a day. * Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.
Interventions
- DRUG Ribavirin
- DRUG Boceprevir
- DRUG Peg-Interferon-alfa 2B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01443923
The ClinicalTrials.gov registry entry for NCT01443923 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 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.
NCT01443923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01443923 about?
NCT01443923 is a clinical study titled "Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV". Background: \- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Rese...
What is the current status of trial NCT01443923?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2011-09. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01443923?
The interventions under investigation include: Ribavirin (DRUG), Boceprevir (DRUG), Peg-Interferon-alfa 2B (DRUG).
Who is sponsoring clinical trial NCT01443923?
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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