Reduced growth hormone (GH) concentrations are observed in men with
human immunodeficiency virus (HIV) lipodystrophy.
To investigate the effects of growth hormone–releasing hormone
(GHRH), a GH secretagogue, in treatment of HIV lipodystrophy.
Design, Setting, and Participants
Randomized, double-blind, placebo-controlled trial conducted at a research
center in the United States between October 2002 and June 2003 and enrolling
31 HIV-infected men aged 18 to 60 years with evidence of lipodystrophy.
Participants were assigned to receive GHRH (1 mg subcutaneously twice
daily) or placebo for 12 weeks.
Main Outcome Measures
The primary outcome was change in concentrations of insulin-like growth
factor 1 (IGF-1) to detect overall change in GH levels in response to GHRH.
Secondary end points included body composition by dual-energy x-ray absorptiometry
and computed tomography, lipodystrophy ratings, and levels of glucose, insulin,
Mean (SD) IGF-1 concentrations increased significantly in the GHRH group
vs the placebo group (104  ng/mL vs 6  ng/mL, P = .004). Lean body mass significantly increased in the GHRH group
vs the placebo group (0.9 [1.3] kg vs −0.3 [1.7] kg, P = .04), trunk fat significantly decreased (−0.4 [0.7] kg vs
0.2 [0.6] kg, P = .03), and the ratio of trunk to
lower extremity fat improved significantly (−0.22 [0.32] vs 0.14 [0.29], P = .005). Abdominal visceral fat was reduced (–19.2
[36.6] cm2 vs 2.3 [24.3] cm2, P =
.07) and the ratio of abdominal visceral fat to abdominal subcutaneous fat
improved significantly more in the GHRH group (–0.19 [0.28] vs 0.07
[0.27], P = .02). Both physician and patient rating
of lipodystrophy in the arms, legs, and abdomen also improved significantly.
Levels of glucose, insulin, and lipids did not change significantly.
GHRH was well tolerated and effectively increased levels of IGF-1 in
HIV-infected men with lipodystrophy. Total and regional body composition improved
in response to GHRH, with increased lean mass and reduced truncal and visceral
fat. Use of GHRH may potentially be a beneficial treatment strategy for this