Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV

Phase 2/3 Completed 20 enrolled Washington University School of Medicine The Campbell Foundation · collab

RandomizedParallel-groupDouble-blind

Summary

We will test the safety of a new class of anti-diabetes compounds (DPPIV-inhibitors) in people living with HIV. Future trials will examine efficacy for treating diabetes and reducing cardiovascular disease risk in people living with HIV.

Timeline

Start: 2010-06
Primary completion: 2011-06
Completion: 2012-06

Outcome

Missed primary endpoint

registry The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant). NCT01093651 ↗

registry The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant). NCT01093651 ↗

Publications

Results Goodwin SR, Reeds DN, Royal M, Struthers H, Laciny E, Yarasheski KE. Dipeptidyl peptidase IV inhibition does not adversely affect immune or virological status in HIV infected men and women: a pilot safety study. J Clin Endocrinol Metab. 2013 Feb;98(2):743-51. doi: 10.1210/jc.2012-3532. Epub 2012 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	—