CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
pioglitazone +2 moredrug
Likely dose
pioglitazone 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00665353
NCT00665353Phase 2Completed
CompareCT.gov

A Pilot Study of Therapy With Pioglitazone Prior to HCV Treatment in HIV-1 and HCV Genotype 1-Infected Subjects With Insulin Resistance Who Are Prior Nonresponders to Peginterferon and Ribavirin Therapy

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Apr 23, 2008·Updated Oct 12, 2018

In Brief

A Phase 2 clinical trial evaluating pioglitazone, peginterferon, and 1 other intervention for HIV-1 and Hepatitis C Co-Infection. Completed, enrolled 19 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 and Hepatitis C Co-Infection
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2008
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.2 years ago

Interventions

pioglitazonedrug

Traditionally used in the treatment of type 2 diabetes to increase insulin sensitivity. Participants will take 30 mg daily in tablet form.

peginterferondrug

Used in the treatment of HCV. Participants will receive 180 mcg subcutaneously once a week.

ribavirindrug

Used in the treatment of HCV. Participants will receive 1000 to 1200 mg orally per day depending on weight.