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A Randomized Placebo-Controlled Study

Sara Dolan, NP; Stephanie Wilkie, NP; Negar Aliabadi, BA; Meghan P. Sullivan, BA; Nesli Basgoz, MD; Benjamin Davis, MD; Steven Grinspoon, MD

Arch Intern Med. 2004;164:897-904.

Background  The prevalence of human immunodeficiency virus (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  A total of 57 HIV-infected women with free testosterone levels less than the median of the reference range and weight less than 90% of ideal body weight or weight loss greater than 10% were randomly assigned to receive transdermal testosterone (4 mg/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 are mean ± SEM unless otherwise specified.

Results  At baseline, subjects were low weight (body mass index [calculated as weight in kilograms divided by the square of height in meters] 20.6 ± 0.4), with significant weight loss from preillness maximum weight (18.7% ± 1.2%), and demonstrated reduced muscle function (upper and lower extremity muscle strength, 83% and 67%, respectively, of predicted range). Testosterone treatment resulted in significant increases in testosterone levels vs placebo (total testosterone: 37 ± 5 vs –2 ± 2 ng/dL [1.3 ± 0.2 vs –0.1 ± 0.1 nmol/L] [P<.001]; free testosterone: 3.7 ± 0.5 vs –0.4 ± 0.3 pg/mL [12.8 ± 1.7 vs –1.4 vs 1.0 pmol/L] [P<.001]) and was well tolerated, without adverse effects on immune function, lipid and glucose levels, liver function, or body composition or the adverse effect of hirsutism. Muscle mass tended to increase (1.4 ± 0.6 vs 0.3 ± 0.8 kg; P = .08), and shoulder flexion (0.4 ± 0.3 vs –0.5 ± 0.3 kg; P = .02), elbow flexion (0.3 ± 0.4 vs –0.7 ± 0.4 kg; P = .04), knee extension (0.2 ± 1.0 vs –1.7 ± 1.3 kg; P = .02), and knee flexion (0.7 ± 0.5 vs 0.3 ± 0.7 kg; P = .04) increased in the testosterone-treated compared with 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.

From the Neuroendocrine Unit and Program in Nutritional Metabolism (Mss Dolan, Wilkie, Aliabadi, and Sullivan and Dr Grinspoon) and Infectious Disease Units (Drs Basgoz and Davis), Massachusetts General Hospital and Harvard Medical School, Boston. Dr Grinspoon has received unrestricted grant support from Serono Inc, Glaxo-Smith Kline, Bristol-Myers Squibb, and Pfizer Inc.

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