Study name: Pioglitazone for Hepatic Steatosis in HIV/HCV Co-infection
Study number: 08-I-0201
Goal of Study: This study will evaluate the potential benefits of 48 weeks of pioglitazone therapy on fatty liver (hepatic steatosis) in HIV/HCV co-infected men and women compared to placebo. The trial will be 96 weeks in duration with a 48-week open-label treatment extension following the 48-week randomized placebo-controlled treatment phase. Subjects will be required to have evidence of hepatic steatosis on biopsy for eligibility.
Study Regimen: The proposed study is a double-blind, randomized, placebo-controlled trial of pioglitazone (45 mg/day) in 50 HIV-infected men and women with HCV and hepatic steatosis. After 48 weeks, all subjects will enter an open-label treatment extension and will be followed for an additional 48 weeks to evaluate the long-term potential benefits of pioglitazone. Therefore, the total duration of participation will be approximately 96 weeks (+/- 8 to 12 weeks for scheduling variations; screening period not included).
Eligibility Criteria:
- You are age 18 or older
- You are HIV and hepatitis C positive
- You are on the same medications for HIV for the past three months OR you have taken no HIV medications for the past three months
- You are in general good health
- You are not currently taking or plan to take medications to treat hepatitis C
- You do not have diabetes
- You do not have hepatitis A or B
- You are not pregnant, and you do not plan to get pregnant
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
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