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Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance
NCT00665353 · View on ClinicalTrials.gov ↗
Study Summary
Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of this study is to determine whether treatment with pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom previous treatment with peginterferon and ribavirin was unsuccessful.
Conditions Studied
Interventions
- DRUG pioglitazone
- DRUG peginterferon
- DRUG ribavirin
Study Locations (8)
New York
- Cornell CRS (7804) — New York
- NY Univ. HIV/AIDS CRS (401) — New York
- AIDS Care CRS (1108) — Rochester
California
- Ucsf Aids Crs (801) — San Francisco
Illinois
- Northwestern University CRS (2701) — Chicago
New Jersey
- New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477) — Newark
Ohio
- Metro Health CRS (2503) — Cleveland
Virginia
- Virginia Commonwealth Univ. Medical Ctr. CRS (31475) — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00665353
The ClinicalTrials.gov registry entry for NCT00665353 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV-1 and Hepatitis C Co-Infection appearing as the primary indexed condition, and to 3 interventions — of which pioglitazone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00665353 reports 8 study locations spanning 6 distinct geographic areas — top geographies include New York, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00665353 about?
NCT00665353 is a clinical study titled "Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance". Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of...
What is the current status of trial NCT00665353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2009-03. Estimated completion is 2011-12.
What conditions does trial NCT00665353 study?
This clinical trial studies the following conditions: HIV-1 and Hepatitis C Co-Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00665353?
The interventions under investigation include: pioglitazone (DRUG), peginterferon (DRUG), ribavirin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00665353?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00665353 being conducted?
This trial has 8 study locations across California, Illinois, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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