HIV-1 and Hepatitis C Co-Infection Clinical Trial
Official title:
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
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.
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.
;