Therapeutic trial of growth hormone releasing factor in HIV patients

Winslow, Dean L.
April 2008
AIDS Alert;Apr2008, Vol. 23 Issue 4, p45
Academic Journal
This multicenter, randomized, placebo-controlled trial of a synthetic GHRH analogue, tesamorelin (1-44 amino acids from the amino terminal of GHRH with a trans-3-hexenoyl group added to the amino terminal to increase the half-life over native GHRH), randomized 412 patients (86% male) to daily subcutaneous tesamorelin vs placebo for 26 weeks. Inclusion criteria included the receipt of at least 8 weeks prior antiretroviral (ARV) therapy and excessive abdominal visceral fat, as defined by various objective morphometric criteria. Use of stable lipid lowering regimen and testosterone replacement within 3 and 6 months of entry, respectively, was permitted. The tesamorelin regimen was well-tolerated, with only a modest increase in treatment related side effects seen in the tesamorelin arm. Peripheral edema, myalgia, hypoesthesia, paresthesia, rash, and injection site reactions were the only remarkable events that seemed to be associated with active drug, but all of these were encountered in less than 10% of patients. Bottom line results showed that tesamorelin therapy resulted in a 15.2% decrease in abdominal visceral fat vs an increase of 5% in the placebo group. Serum triglycerides decreased by 50 mg/dL in the tesamorelin group vs an increase of 9 mg/dL in the placebo group. Similarly, the total/HDL cholesterol ratio decreased by 0.31 in the treated vs increased by 0.21 in the placebo group. Levels of insulin-like growth factor (IGF-I), which mediates the effect of hGH on tissue, increased by 81% in the tesamorelin group and decreased by 5% in the placebo group. No differences in glycemic measurements were observed between the groups.


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