HIV Clinical Trial
Official title:
Pioglitazone for Hepatic Steatosis in HIV/HCV Co-infection
This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in
patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying
insulin resistance in patients with HIV and HCV co-infections is associated with
inflammatory changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is
a drug that helps to reduce the body's resistance to insulin. It is approved by the Food and
Drug Administration to treat diabetes.
Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be
eligible for this study. Candidates are screened with a medical history and physical
examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure
liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis.
- Participants are randomly assigned to take either pioglitazone therapy or placebo for
48 weeks. This is followed by a second 48-week treatment period in which all
participants take pioglitazone.
- There are approximately 12 visits during the 96 weeks of the study. Participants will
receive a physical assessment, blood and urine tests at each visit. In addition,
periodic assessments of dietary habits, body composition, oral glucose tolerance
testing, and health related quality of life questionnaires will be completed.
- A repeat MRI of the liver is performed at 48 weeks and at the end of the study to
evaluate any potential changes in liver fat and inflammation. In addition, there is a
follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.
Following the introduction of effective antiretroviral therapy for HIV, the management of
co-morbidities such as hepatitis C virus (HCV) has taken on increasing significance in the
care and health maintenance of chronically infected patients. HCV co-infection is common in
HIV, with an estimated prevalence of 30 percent among HIV-infected adults in the US.
Further, the reported prevalence of hepatic steatosis in HIV/HCV co-infection is between
40-67 percent.
In recent years, the significance of hepatic steatosis and accompanying insulin resistance
in HCV has gained increasing recognition. For example, steatosis is associated with
increased rates of necro-inflammatory change and fibrosis in HIV/HCV co-infected patients.
Furthermore, studies showed that, among non-HIV infected HCV patients, the presence of
steatosis and/or insulin resistance was associated with poorer response to HCV therapy.
These observations have led to research interest in treating hepatic steatosis in HCV,
particularly in the context of pegylated interferon and ribavirin therapy.
Administration of the thiazolidinedione, pioglitazone, leads to significant reductions in
hepatic steatosis, inflammation and in some cases fibrosis in patients with non-alcoholic
steatohepatitis (NASH). Therefore, the potential benefits of pioglitazone therapy in the
setting of HIV/HCV co-infection and hepatic steatosis will be determined. The proposed study
is a 48-week, double-blind, randomized placebo-controlled trial of pioglitazone (45 mg/day)
in 50 HIV/HCV-infected men and women. After the 48-week randomized portion of the trial, all
participants will enter a 48-week open treatment extension arm irrespective of original
randomization. It is anticipated that 100 subjects will be needed to be screened to identify
a sufficient number of eligible participants to enroll in the study.
The primary outcome variable of interest in this trial will be the change in hepatic fat
content measured by magnetic resonance (MR) spectroscopy. Important secondary outcomes will
be histologic improvement on liver biopsy performed at baseline and 48 weeks, as well as
improvements in transaminase levels and insulin resistance. The open treatment extension
will allow all participants an opportunity to receive active study medication and it will
allow the potential benefits of additional pioglitazone therapy to be assessed. In this way,
important information about the efficacy of pioglitazone to treat hepatic steatosis and
improve the metabolic profile in HIV/HCV co-infected patients will be obtained.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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