A double-blind, placebo-controlled trial of testosterone therapy for HIV-positive men with hypogonadal symptoms

Background: The goal was to evaluate the efficacy of testosterone in allevi ation of hypogonadal symptoms (diminished libido, depressed mood, low energ y, and depleted muscle mass) in men with symptomatic human immunodeficiency virus illness. Methods: Seventy-four patients were enrolled in a double-blind, placebo-con trolled 6-week trial with biweekly testosterone injections, followed by 12 weeks of open-label maintenance treatment. Major outcome measures were Clin ical Global Impressions Scale ratings for libido, mood, energy, and erectil e function; Hamilton Depression Rating Scale scores, and Chalder Fatigue Sc ale scores. Body composition changes were assessed with bioelectric impedan ce analysis. Results: Seventy men completed the 6-week trial. Response rates, defined as much or very much improved libido, were 74% (28/38) for patients randomize d to testosterone, and 19% (6/32) for placebo-treated patients (P<.001). Of the 62 completers with fatigue at baseline, 59% (20/34) receiving testoste rone and 25% (7/28) receiving placebo reported improved energy (P<.01). Amo ng the 26 completers with an Axis I depressive disorder at baseline, 58% of the testosterone-treated patients reported improved mood compared with 14% of placebo-treated patients (Fisher exact test =.08). With testosterone tr eatment, average increase in muscle mass over 12 weeks was 1.6 kg for the w hole group, and 2.2 kg for the 14 men with wasting at baseline. Improvement on all parameters was maintained during subsequent open-label treatment fo r up to 18 weeks. Conclusion: Testosterone is well tolerated and effective in the short-term treatment of symptoms of clinical hypogonadism in men with symptomatic huma n immunodeficiency virus illness, restoring libido and energy, alleviating depressed mood, and increasing muscle mass.