A TRIAL OF TESTOSTERONE THERAPY FOR HIV-ASSOCIATED WEIGHT-LOSS

Objective: Weight loss in HIV-infected patients is extremely common an d is associated with increased morbidity and mortality. Decreased test osterone concentrations occur commonly in patients with HIV disease an d are associated with weight loss. This study assessed the effect of t estosterone therapy on HIV associated weight loss in patients with AID S. 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 rand omized in a double-blind manner to receive 200 mg of testosterone cypi onate or placebo intramuscularly every 2 weeks for 3 months. Patients were then crossed to receive the alternate treatment for the next 3 mo nths. Outcome variables included weight, skin Told measurement, a qual ity-of-life questionnaire, Karnofsky score, T-cell subset analysis, co mplete blood count, routine blood chemistry measurements and free test osterone concentration. Results: Thirty-nine patients entered the stud y. Or 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 te stosterone and placebo treatment. Analysis of the first 3 months only for the 35 patients who completed it did not show any significant diff erence between the effects of testosterone and placebo treatment on we ight gain. Patients treated with testosterone reported improved overal l 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 wel l-being and possibly some increase in muscle strength. This randomized , double-blinded study does not confirm the results of other recent st udies which show potential benefits of testosterone and its analogs wh en used as a treatment for weight loss in HIV-positive patients.