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14th International AIDS ConferenceBarcelona, Spain — July 7-12, 2002 |
Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbOr18
BACKGROUND: This placebo-controlled, multi-center trial evaluated recombinant human growth hormone (r-hGH, Serostim®) in HIV-associated adipose redistribution syndrome (HARS). HARS patients (pts) have pathological accumulation of visceral adipose tissue (VAT), often with metabolic abnormalities.
METHODS: To be eligbile, men (M) needed a waist circumference (WC) >88.2 cm and wasit/hip ratio (WHR) > .95 and women (W) a WC >75.3 cm and WHR >.09. Pts were randomized (1:1:1) to placebo (P) or GH 4mg dosed daily (DD) or on alternate days (AD) for 12 weeks (wks). VAT was assessed by CT scan, body composition by DXA, and quality of life (QOL) by questionnaire. Non-HDL cholesterol (C) was calculated as total C minus HDL.
RESULTS: Of 239 pts who received treatment and follow-up (78 P, 82 DD, 79 AD), 13% were female and 20% non-caucasian. Baseline mean age was 45 yrs, body mass index 27 kg/m2, WC98 cm, WHR 1.03, and VAT at L4-5 331 cm2 in men (M), 240 cm2 in women (W). At 12 wks, compared to P, VAT decreased on DD (p<0.001 and AD (p<0.052). On DXA, total body fat decreased (p<0.001, both groups) predominatly due to truncal fat (>84%). Net weight increased <1.0kg reflecting LBM gain (p<0.001, both groups). Mean non-HDL C, 177 mg/dl at baseline, decreased on DD and AD (-18 and -12 mg/dl, p<.001 and 0.006, respectively) compared to P. On factor analysis, the QOL change from baseline favorable for DD (p<.01) and 0.34 SD unites more for AS (p<.05) as compared to P. Treatment was generally well-tolerated with most common adverse events arthralgia and glycemia that was generally modest and asymptomatic.
CONCLUSIONS: In this placebo-controlled study of r-hGH in HARS, Serostim® 4mg/day effectively reduced VAT and truncal fat without weight loss, while improving QOL. Treatment also reduced pro-atherogenic non-HDL cholesterol.
Presenting author: Donald P Kotler
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LbOr18
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