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Submitted on December 10, 2004
Accepted on April 7, 2005
Chair of Paediatrics, L. Sacco Hospital, University of Milan; Laboratory of Paediatric Endocrinology, IRCCS H S. Raffaele, Milan, Italy; Department of Pharmacology, IRCCS S. Matteo Hospital, Pavia, Italy
* To whom correspondence should be addressed. E-mail: alessandra.vigano{at}unimi.it.
Context. Recombinant human growth hormone (rhGH) reduces excess accumulation of intra-abdominal adipose tissue (IAT) in lipodystrophic HIV-infected adults, while data in pediatric patients are lacking.
Objective. To assess the efficacy of rhGH treatment on lipodystrophy in HIV-infected adolescents.
Design. Prospective, 24 weeks open-label study of rhGH.
Setting. Referral center for pediatric HIV infection.
Patients and Other Participants. Eight HIV-infected adolescents (13.7-18.5 yr), with abnormal IAT accumulation (>41 cm2 at L4-MRI) and ninety-seven, healthy controls (HC) (9.5-19.9 yr), were enrolled.
Intervention. RhGH was given by sc injection at a daily dose of 0.028 mg/kg.
Main Outcome Measures. The main outcome was change in IAT at L4-MRI. Body composition by dual-energy x-ray absorptiometry (DXA), glucose and lipid metabolism and IGF-1 changes were also evaluated.
Results. All patients completed the study period; none of them showed adverse event and no changes on the daily dose of rhGH was required. The treatment was associated with a mean height increase of 2.4 cm. From baseline to week 24, IAT area decreased significantly by a median of 34.5% (-19.2 to -70%). Fat mass decreased significantly in patients compared with HC, with a median loss of total, trunk, arms and legs fat mass of 10.4, 10.9, 12.7 and 5.4% respectively. Total, arms, and legs lean masses increased significantly compared with HC. IGF-1 increased significantly, but supraphysiologic values of mild degree (2-23% over the upper normal limit) were detected only in 9/24 samples. No significant effects on glucose metabolism, triglyceride and cholesterol levels were observed.
Conclusions. Our data showed that rhGH 0.028 mg/kg/daily for 24 weeks in HIV-infected adolescents reduces IAT, trunk, and also limbs fat, while increasing lean mass. Overall short-term rhGH is well tolerated and is not associated with a worsening of glucose and lipid metabolism.
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