Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide
extended-release formulation) on blood sugar levels and serum markers of inflammation in a
cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated
diabetes mellitus. Previous studies have shown that high levels of persistent systemic
inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected
persons on cART (a group at very high risk of atherosclerosis and myocardial infarction).
Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV
infected persons, which suggests that this agent may represent a unique and preferred
medication for the treatment of insulin resistance in HIV-infected adults. The Investigators
hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance
and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and
highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the
development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated
adults.
Phase:
Phase 4
Details
Lead Sponsor:
Vanderbilt University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)