Background:  HIV disease is increasing among women, many of whom remain symptomatic with low weight and poor functional status. Although androgen levels may often be reduced in such patients, the safety, tolerability, and efficacy of testosterone administration in this population remains unknown.

Methods:  In this double-blind placebo-controlled study, 57 HIV-infected women whose free testosterone measured less than the median of the normal reference range and whose weight was <90% ideal body weight or whose weight loss was >10% were randomly assigned to receive transdermal testosterone (4 mg per patch) twice weekly or placebo for 6 months. Muscle mass was assessed by urinary creatinine excretion. Muscle function was assessed by the Tufts Quantitative Muscle Function Test. Treatment effect at 6 months was determined by analysis of covariance.

Results:  At baseline, subjects were low weight (body mass index = 20.6±0.4 kg/m²), with significant weight loss from pre-illness maximum (18.7±1.2%), and demonstrated reduced muscle function (upper and lower extremity muscle strength, 83% and 67% of predicted, respectively). Testosterone treatment resulted in significant increases in testosterone levels (total testosterone: 37±5 vs -2±2 ng/dL, p <0.0001; free testosterone: 3.7±0.5 vs -0.4±0.3 pg/mL, p < 0.0001, testosterone vs placebo) and was well tolerated, without adverse effect on immune function, lipids, glucose, liver function, body composition, or hirsutism. Muscle mass tended to increase (1.4±0.6 vs 0.3±0.8 kg, p = 0.082) and shoulder flexion (0.4±0.3 vs -0.5±0.3 kg, p=0.023), elbow flexion (0.3±0.4 vs -0.7±0.4 kg, p = 0.036), knee extension (0.2±1.0 vs -1.7±1.3 kg, p = 0.019), and knee flexion (0.7±0.5 vs 0.3±0.7 kg, p = 0.036) increased in the testosterone compared to the placebo-treated subjects.

Conclusions:  Testosterone administration is well-tolerated and increases muscle strength in low-weight HIV-infected women. Testosterone administration may be a useful adjunctive therapy to maintain muscle function in symptomatic HIV-infected women. This study is complete and all results are final.

Keywords: AIDS Wasting Syndrome; Testosterone; HIV-Infected Women