Objective: Weight loss in HIV-infected patients is extremely common and is associated with increased morbidity and mortality. Decreased testosterone concentrations occur commonly in patients with HIV disease and are associated with weight loss. This study assessed the effect of testosterone therapy on HIV associated weight loss in patients with AIDS.
Methods: Forty HIV-seropositive patients with CD4+ counts of < 2 x 10(5)/l and weight loss greater than 5% of usual body weight were randomized in a double-blind manner to receive 200 mg of testosterone cypionate of placebo intramuscularly every 2 weeks for 3 months. Patients were then crossed to receive the alternate treatment for the next 3 months. Outcome variables included weight, skin fold measurement, a quality-of-life questionnaire, Karnofsky score, T-cell subset analysis, complete blood count, routine blood chemistry measurements and free testosterone concentration.
Results: Thirty-nine patients entered the study. Of these, 35 completed the first 3-month period (18 on placebo, 17 on testosterone) and 23 completed the whole 6 month trial. Analysis of these 23 patients did not show any significant differences between testosterone and placebo treatment. Analysis of the first 3 months only for the 35 patients who completed it did not show any significant difference between the effects of testosterone and placebo treatment on weight gain. Patients treated with testosterone reported improved overall well-being (P = 0.03) and a trend towards increased muscle strength (P = 0.08). There was no difference between the two groups in terms of side-effects or other effects on hematopoetic, liver, renal, or immune function.
Conclusions: Treatment with testosterone cypionate compared with placebo did not result in significant weight gain. Testosterone supplementation did appear to produce an improved overall sense of well-being and possibly some increases in muscle strength. This randomized, double-blinded study does not confirm the results of other recent studies which show potential benefits of testosterone and its analogs when used as a treatment for weight loss in HIV-positive patients.