Clinical Research

Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension

Falutz J, Potvin D, Mamputu JC, et al. (2010). JAIDS Journal of Acquired Immune Deficiency Syndromes.

Summary

A 12-month randomised double-blind trial in people with HIV on antiretroviral therapy who had excess abdominal fat. Over the first six months, visceral adipose tissue fell by about 11 percent in the tesamorelin group against under 1 percent on placebo, with improvements in trunk fat, waist circumference and waist-to-hip ratio and no change in limb or subcutaneous abdominal fat. IGF-1 rose; glucose measures did not change. Participants and physicians both rated abdominal appearance as improved. Those who continued for 12 months reached about an 18 percent reduction, and those switched from tesamorelin to placebo rapidly lost the gain. One of the two trials behind the drug's US approval.