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NCT00742326 · ClinicalTrials.gov registry record · Phase 4
Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT00742326 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 13 participants.
The verdict
NCT00742326, 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
- 13 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that helps to reduce the body's resistance to insulin. It is approved by the Food and Drug Administration to treat diabetes. Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis. * Participants are randomly assigned to take either pioglitazone therapy or placebo for 48 weeks. This is followed by a second 48-week treatment period in which all participants take pioglitazone. * There are approximately 12 visits during the 96 weeks of the study. Participants will receive a physical assessment, blood and urine tests at each visit. In addition, periodic assessments of dietary habits, body composition, oral glucose tolerance testing, and health related quality of life questionnaires will be completed. * A repeat MRI of the liver is performed at 48 weeks and at the end of the study to evaluate any potential changes in liver fat and inflammation. In addition, there is a follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00742326
The ClinicalTrials.gov registry entry for NCT00742326 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 13 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 2 interventions - of which Placebo is the first listed.
NCT00742326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00742326 about?
NCT00742326 is a clinical study titled "Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections". This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory changes, liver fibrosis and...
What is the current status of trial NCT00742326?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2008-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00742326?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00742326?
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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