Preliminary findings on 178 people with HIV-associated wasting suggest that mammalian cell-derived recombinant human growth hormone can have a positive effect in arresting the condition and may present an advantage over nutritional support or appetite stimulation, according to a presentation by Morris Schambelan, San Francisco General Hospital, at the 10th International AIDS Conference in Yokohama, Japan.
Dr Schambelan said that the results, from a Phase III, placebo-controlled study, showed an increase in body weight, specifically lean body mass, favorable changes in body composition and, based on treadmill tests, improved endurance. He continued that, unlike other therapies which primarily increase accumulation of fat, it was found that rhGH offers unique effects for people with AIDS wasting.
Because of the results, Serono Laboratories, the study's sponsor, has contacted the US Food and Drug Administration and is exploring an expanded study program via an Investigational New Drug application. The company expects a rapid approval for the program.
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