Recombinant human growth hormone to treat HIV-associated adipose redistribution syndrome: 12 week induction and 24-week maintenance therapy.
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.
Grunfeld
Carl
C
University of California, San Francisco Veterans Affairs Medical Center, and Columbia/St. Luke's-Roosevelt Hospital, New York, NY, USA.
Thompson
Melanie
M
Brown
Stephen J
SJ
Richmond
Gary
G
Lee
Daniel
D
Muurahainen
Norma
N
Kotler
Donald P
DP
D000328:Adult; D019380:Anti-HIV Agents; D001823:Body Composition / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D050152:Intra-Abdominal Fat / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
D019380:Anti-HIV Agents; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D002784:Cholesterol