Pioglitazone to Treat Fatty Liver in People With HIV Infection
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can
benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as
steatosis) have been linked to diabetes and long-term liver damage in some patients.
Pioglitazone has been shown to improve fatty liver in people without HIV; this study will see
if it is beneficial for people with HIV as well.
HIV-infected patients 18 years of age and older with increased fat in the liver may be
eligible for this study. Screening includes a CT scan and liver biopsy (withdrawal of a small
sample of liver tissue through a needle).
Participants are randomly assigned to take either 45 mg of pioglitazone or placebo (sugar
pill) by mouth once a day for 48 weeks. At the end of 48 weeks, all participants stop taking
their medication and are followed for an additional 48 weeks to see what, if any benefits, of
pioglitazone persist after treatment is stopped. In addition to taking the study medication,
participants undergo the following procedures:
- Visits to the NIH Clinical Center over a period of approximately 2 years at day 0 and
weeks 2, 8, 16, 24, 32, 40, 48, 52, 72, and 96. Most visits take about 1 hour and
include blood drawing for various laboratory tests.
- Insulin clamp test at day 0 and weeks 24 and 48 to see how the body processes glucose.
This test takes 4 to 6 hours and may include an overnight stay at the Clinical Center. A
catheter (plastic tube) is placed in a vein in the arm to infuse insulin and another is
placed in a vein on the back of the hand to draw blood samples. Blood sugar is checked
frequently and glucose is given to keep blood sugar at normal values.
- Nutrition evaluations at day 0 and weeks 24 and 48. Subjects write down all the food
they eat and drink for 4 days before the visit. They meet with a nutritionist to review
the food record and to complete simple measurements of body fat and shape.
- CT scan of liver and abdomen at weeks 24, 48, 72 and 96.
- Liver biopsy at week 48.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)