The use of a transscrotal testosterone delivery system in the treatment ofpatients with weight loss related to human immunodeficiency virus infection

PURPOSE: Weight loss is a strong predictor of morbidity and mortality in hu man immunodeficiency virus (HIV)-infected patients. Men with acquired immun odeficiency syndrome (AIDS) lose body cell mass. Hypogonadism is also commo n. This study tested the efficacy of a testosterone transscrotal patch (6 m g/day) in improving body cell mass and treating hypogonadism in these patie nts. SUBJECTS AND METHODS: This multicenter, randomized, double-blinded, placebo -controlled trial was conducted from August 1995 to October 1996 in 133 men , 18 years of age and older, who had AIDS, 5% to 20% weight loss, and eithe r a low morning serum total testosterone level (<400 ng/dL) or a low free t estosterone level (<16 pg/mL). Outcomes included weight, body cell mass as measured using bioelectrical impedance analysis, quality of life, and morni ng measurements of serum testosterone and dihydrotestosterone levels, lymph ocyte subsets, and HIV quantification. RESULTS: There were no significant differences in baseline weight, CD4 cell counts, or HIV serum viral quantification between treatment arms. Morning total and free testosterone levels increased in those treated with testoste rone, but not with placebo. Following 12 weeks of treatment there were no d ifferences (testosterone-placebo) in mean weight change (-0.3 kg [95% confi dence interval (CI): -1.4 to 0.8]) or, body cell mass (-0.2 kg [95% CI: - 1 .0 to 0.6]) in the two groups. There were also no changes in quality of lif e in either group. CONCLUSION: Hypogonadal men with AIDS and weight loss can achieve adequate mooting serum sex hormone levels using a transscrotal testosterone patch. H owever, this system of replacement does not improve weight, body cell mass, or quality of life. (C) 1999 by Excerpta Medica, Inc.