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A Randomized Controlled Trial

Polyxeni Koutkia, MD, MA; Bridget Canavan, BA; Jeff Breu, BS; Martin Torriani, MD; John Kissko, MS; Steven Grinspoon, MD

JAMA. 2004;292:210-218.

Context  Reduced growth hormone (GH) concentrations are observed in men with human immunodeficiency virus (HIV) lipodystrophy.

Objective  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.

Interventions  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, and lipids.

Results  Mean (SD) IGF-1 concentrations increased significantly in the GHRH group vs the placebo group (104 [110] ng/mL vs 6 [44] 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.

Conclusions  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 population.

Author Affiliations: Massachusetts General Hospital Program in Nutritional Metabolism and Neuroendocrine Unit (Drs Koutkia and Grinspoon, Ms Canavan) and Department of Radiology (Dr Torriani and Mr Kissko), Harvard Medical School, Boston, Mass; General Clinical Research Center, Massachusetts Institute of Technology, Cambridge (Mr Breu).

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