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Shalender Bhasin, MD; Thomas W. Storer, PhD; Marjan Javanbakht, MPH; Nancy Berman, PhD; Kevin E. Yarasheski, PhD; Jeffrey Phillips, MD; Marjorie Dike, PhD; Indrani Sinha-Hikim, PhD; Ruoquing Shen, MD; Ron D. Hays, PhD; Gildon Beall, MD

JAMA. 2000;283:763-770.

Context  Previous studies of testosterone supplementation in HIV-infected men failed to demonstrate improvement in muscle strength. The effects of resistance exercise combined with testosterone supplementation in HIV-infected men are unknown.

Objective  To determine the effects of testosterone replacement with and without resistance exercise on muscle strength and body composition in HIV-infected men with low testosterone levels and weight loss.

Design and Setting  Placebo-controlled, double-blind, randomized clinical trial conducted from September 1995 to July 1998 at a general clinical research center.

Participants  Sixty-one HIV-infected men aged 18 to 50 years with serum testosterone levels of less than 12.1 nmol/L (349 ng/dL) and weight loss of 5% or more in the previous 6 months, 49 of whom completed the study.

Interventions  Participants were randomly assigned to 1 of 4 groups: placebo, no exercise (n = 14); testosterone enanthate (100 mg/wk intramuscularly), no exercise (n = 17); placebo and exercise (n = 15); or testosterone and exercise (n = 15). Treatment duration was 16 weeks.

Main Outcome Measures  Changes in muscle strength, body weight, thigh muscle volume, and lean body mass compared among the 4 treatment groups.

Results  Body weight increased significantly by 2.6 kg (P<.001) in men receiving testosterone alone and by 2.2 kg (P = .02) in men who exercised alone but did not change in men receiving placebo alone (-0.5 kg; P = .55) or testosterone and exercise (0.7 kg; P = .08). Men treated with testosterone alone, exercise alone, or both experienced significant increases in maximum voluntary muscle strength in leg press (range, 22%-30%), leg curls (range, 18%-36%), bench press (range, 19%-33%), and latissimus pulls (range, 17%-33%). Gains in strength in all exercise categories were greater in men assigned to the testosterone-exercise group or to the exercise-alone group than in those assigned to the placebo-alone group. There was a greater increase in thigh muscle volume in men receiving testosterone alone (mean change, 40 cm³; P<.001 vs zero change) or exercise alone (62 cm; P = .003) than in men receiving placebo alone (5 cm³; P = .70). Average lean body mass increased by 2.3 kg (P = .004) and 2.6 kg (P<.001), respectively, in men who received testosterone alone or testosterone and exercise but did not change in men receiving placebo alone (0.9 kg; P = .21).Hemoglobin levels increased in men receiving testosterone but not in those receiving placebo.

Conclusion  Our data suggest that testosterone and resistance exercise promote gains in body weight, muscle mass, muscle strength, and lean body mass in HIV-infected men with weight loss and low testosterone levels. Testosterone and exercise together did not produce greater gains than either intervention alone.

Author Affiliations: Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science (Drs Bhasin, Dike, Sinha-Hikim, and Shen and Ms Javanbakht), and Department of General Internal Medicine and Health Service Research (Dr Hays), University of California, Los Angeles; Laboratory for Exercise Sciences, El Camino College (Dr Storer), and Departments of Pediatrics (Dr Berman), Radiology (Dr Phillips), and Medicine (Dr Beall), Harbor-University of California, Los Angeles Medical Center, Torrance; and Division of Metabolism, Endocrinology, and Diabetes, Washington University Medical School, St Louis, Mo (Dr Yarasheski).

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