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Effects of Testosterone Replacement in Human Immunodeficiency Virus-Infected Women with Weight Loss

Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science (H.H.C., P.B.G., T.W.S., O.M.C., L.W., A.B.S., C.P., R.P.M., I.S.-H., R.S., J.D., C.D., M.L.L., S.B.), Los Angeles, California 90059; El Camino College (T.W.S.), Torrance, California 90506; ARUP Institute for Clinical and Experimental Pathology (C.D., M.M.K., A.L.R., A.W.M.), Salt Lake City, Utah 84124; and Division of General Internal Medicine, Department of Medicine, University of California (R.D.H.), Los Angeles, California 90095-1726

Address all correspondence and requests for reprints to: Dr. Shalender Bhasin, University of California School of Medicine, Drew-University of California-Los Angeles Reproductive Science Research Center, Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California 90059. E-mail: sbhasin{at}ucla.edu.

The objective of this study was to determine whether physiological testosterone replacement increases fat-free mass (FFM) and muscle strength and contributes to weight maintenance in HIV-infected women with relative androgen deficiency and weight loss. Fifty-two HIV-infected, medically stable women, 18–50 yr of age, with more than 5% weight loss over 6 months and testosterone levels below 33 ng/dl were randomized into this double-blind, placebo-controlled trial of 24-wk duration. Subjects in the testosterone group applied testosterone patches twice weekly to achieve a nominal delivery of 300 µg testosterone over 24 h. Data were evaluable for 44 women. Serum average total and peak testosterone levels increased significantly in the testosterone group, but did not change in the placebo group. However, there were no significant changes in FFM (testosterone, 0.7 ± 0.4 kg; placebo, 0.3 ± 0.4 kg), fat mass (testosterone, 0.3 ± 0.7 kg; placebo, 0.6 ± 0.7 kg), or body weight (testosterone, 1.0 ± 0.9 kg; placebo, 0.9 ± 0.8 kg) between the two treatment groups. There were no significant changes in leg press strength, leg power, or muscle fatigability in either group. Changes in quality of life, sexual function, cognitive function, and Karnofsky performance scores did not differ significantly between the two groups. High-density lipoprotein cholesterol levels decreased significantly in the testosterone group. The patches were well tolerated. We conclude that physiological testosterone replacement was safe and effective in raising testosterone levels into the mid to high normal range, but did not significantly increase FFM, body weight, or muscle performance in HIV-infected women with low testosterone levels and mild weight loss. Additional studies are needed to fully explore the role of androgens in the regulation of body composition in women.

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