NCT00665353

Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

New and better strategies for the treatment of HCV in HIV/HCV-coinfected people are urgently needed. Standard therapy for HCV includes treatment with peginterferon plus ribavirin. Peginterferon is a modified form of the drug interferon and is used either alone or in combination with ribavirin for the treatment of HCV. Ribavirin works by stopping HCV from multiplying inside the body. Sustained virologic response rates in past large studies of peginterferon plus ribavirin used for treating HCV types 1 or 4 ranged from 11% to 29%. Studies have shown that insulin resistance in HCV-infected people who are HIV uninfected leads to poorer HCV treatment response. Improving the body's response to insulin may also improve the outcome of treatment for HCV. Participants in this study will take pioglitazone alone for up to 28 weeks. At Entry and Weeks 2, 4, 8, 12,18, and 24 participants will receive clinical assessments. At Week 24, participants will undergo additional tests to ensure that they can enter Step 2 of the study. Participants who are able to continue will then take peginterferon and ribavirin in addition to the pioglitazone for up to 48 additional weeks. Clinical assessments will take place at the time of entry and Weeks 2, 4, 8, 12, 16, and 24 of Step 2. Participants who do not exhibit a response to the treatment at Weeks 12 or 24 will not continue Step 2, as it is unlikely that further treatment will elicit a response. Participants who continue in the study will return to the study site for clinical assessments at Weeks 32, 40, and 48 of Step 2. Follow-up visits will be held at Weeks 60 and 72. The assessments done at clinic visits may include any or all of the following tests: thyroid function, hematology and chemistry, fasting plasma glucose, liver function, gamma-glutamyl transferase, pregnancy, CD4/CD8, HIV-1 RNA, qualitative HCV RNA, and quantitative HCV RNA. On November 18, 2011 the study was closed to accrual due to not meeting targeted accrual goals.

Conditions

• HIV-1 and Hepatitis C Co-Infection

Interventions

Type	Name	Description
DRUG	pioglitazone	Traditionally used in the treatment of type 2 diabetes to increase insulin sensitivity. Participants will take 30 mg daily in tablet form.
DRUG	peginterferon	Used in the treatment of HCV. Participants will receive 180 mcg subcutaneously once a week.
DRUG	ribavirin	Used in the treatment of HCV. Participants will receive 1000 to 1200 mg orally per day depending on weight.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2008-04-23
• Last updated: 2018-10-12
• Results posted: 2012-09-13

Locations

8 sites across 1 country: United States