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Recombinant Human Growth Hormone to Treat HIV-Associated Adipose Redistribution Syndrome: 12-Week Induction and 24-Week Maintenance Therapy

Grunfeld, Carl MD, PhD*; Thompson, Melanie MD; Brown, Stephen J MD; Richmond, Gary MD§; Lee, Daniel MD; Muurahainen, Norma MD, PhD; Kotler, Donald P MD#on behalf of the Study 24380 Investigators Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: July 1st, 2007 - Volume 45 - Issue 3 - p 286-297
doi: 10.1097/QAI.0b013e31804a7f68
Clinical Science

Background: HIV-associated adipose redistribution syndrome (HARS) is an HIV-associated disorder characterized by excess truncal fat, including visceral adipose tissue (VAT).

Methods: From baseline to week 12 in this randomized, double-blind, placebo (PL)-controlled, multicenter trial investigating effects of recombinant human growth hormone (r-hGH; Serostim; EMD Serono Inc., Rockland, MA) in patients with HARS, 325 received induction (4 mg/d of r-hGH) or PL. At week 12, patients who initially received induction were rerandomized to 2 mg of r-hGH on alternate days (maintenance) or PL to week 36. Patients who initially received PL later received 4 mg/d of r-hGH. Change in VAT was the primary outcome. Key secondary outcomes included changes in non-high-density lipoprotein cholesterol (non-HDL-C) and limb fat.

Results: At week 12, induction therapy resulted in decreased VAT (−32.6 vs. 0.5 cm2; P < 0.001), limb fat (−0.4 vs. 0.2 kg; P < 0.001), and non-HDL-C (−13.0 vs. −2.8 mg/dL; P = 0.023) compared with PL. On r-hGH induction-maintenance (baseline to week 36), patients sustained losses in VAT and trunk fat but not losses of subcutaneous fat in the abdomen or limbs. Also, non-HDL-C remained significantly decreased on r-hGH but not on PL maintenance.

Conclusions: In patients with HARS, r-hGH induction-maintenance therapy produces greater relative losses of VAT and trunk fat than of subcutaneous fat and also has beneficial effects on the lipid profile.

From the *Division of Endocrinology, University of California, San Francisco Veterans Affairs Medical Center, San Francisco, CA; †AIDS Research Consortium, Atlanta, GA; ‡AIDS Research Alliance, West Hollywood, CA; §Richmond Clinic, Fort Lauderdale, FL; ∥University of California, San Diego, Antiviral Research Center, San Diego, CA; ¶EMD Serono Inc., Clinical Development, Rockland, MA; and #Gastrointestinal Immunology, Columbia/St. Luke's-Roosevelt Hospital, New York, NY.

Received for publication September 29, 2006; accepted February 12, 2007.

Funding for this study was provided by EMD Serono Inc., Rockland, MA.

Presented in part at the 16th Annual AIDS Conference, Toronto, Ontario, Canada, August 13-18, 2006.

Reprints: Norma Muurahainen, MD, PhD, EMD Serono Inc., One Technology Place, Rockland, MA 02370 (e-mail: norma.muurahainen@emdserono.com).

© 2007 Lippincott Williams & Wilkins, Inc.