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Effects of Androgen Administration in Men with the AIDS Wasting Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Steven Grinspoon, MD; Colleen Corcoran, ANP; Hasan Askari, MBBS; David Schoenfeld, PhD; Lisa Wolf, RN; Belton Burrows, MD; Mark Walsh, MS; Douglas Hayden, MA; Kristin Parlman, MSPT; Ellen Anderson, MS, RD; Nesli Basgoz, MD; and Anne Klibanski, MD
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For author affiliations and current author addresses, see end of text. Acknowledgments: The authors thank Martin Hirsch, MD, for continued support; Benjamin Davis, MD, Howard Heller, MD, and John Doweiko, MD, for help with patient care and recruitment; Andrew Guccione, PhD, Gregory Newbauer, BA, Madeline Costello, PT, Judy Krempin, BS, Maxine Sleeper, BA, and Kristen Lee, BS, for technical assistance; and Karen Hopcia, RN, and the nursing and nutrition staffs of the Massachusetts General Hospital General Clinical Research Center for dedicated patient care. Grant Support: In part by National Institutes of Health grants R01-DK49302, MO1-RR01066, P32-DK07028, and F32-DK09218. Requests for Reprints: Steven Grinspoon, MD, Neuroendocrine Unit, Bulfinch 457B, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114. Current Author Addresses: Drs. Grinspoon and Klibanski and Ms. Corcoran: Neuroendocrine Unit, Bulfinch 457B, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1998;129(1):18-26. doi:10.7326/0003-4819-129-1-199807010-00005
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Background: Development of successful anabolic strategies to reverse the loss of lean body mass is of critical importance to increase survival in men with the AIDS wasting syndrome. Hypogonadism, an acquired endocrine deficiency state characterized by loss of testosterone, occurs in more than half of all men with advanced HIV disease. It is unknown whether testosterone deficiency contributes to the profound catabolic state and loss of lean body mass associated with the AIDS wasting syndrome.

Objective: To investigate the effects of physiologic testosterone administration on body composition, exercise functional capacity, and quality of life in androgen-deficient men with the AIDS wasting syndrome.

Design: Randomized, double-blind, placebo-controlled study.

Setting: University medical center.

Patients: 51 HIV-positive men (age 42 ± 8 years) with wasting (body weight < 90% of ideal body weight or weight loss > 10% of baseline weight) and a free testosterone level less than 42 pmol/L (normal range for men 18 to 49 years of age, 42 to 121 pmol/L [12.0 to 35.0 pg/mL]).

Intervention: Patients were randomly assigned to receive testosterone enanthate, 300 mg, or placebo intramuscularly every 3 weeks for 6 months.

Measurements: Change in fat-free mass was the primary end point. Secondary clinical end points were weight, lean body mass, muscle mass, exercise functional capacity, and change in perceived quality of life. Virologic variables were assessed by CD4 count and viral load.

Results: Compared with patients who received placebo, testosterone-treated patients gained fat-free mass ( −0.6 kg and 2.0 kg; P = 0.036), lean body mass (0.0 kg and 1.9 kg; P = 0.041), and muscle mass ( −0.8 kg and 2.4 kg; P = 0.005). The changes in weight, fat mass, total-body water content, and exercise functional capacity did not significantly differ between the groups. Patients who received testosterone reported benefit from the treatment (P = 0.036), feeling better (P = 0.033), improved quality of life (P = 0.040), and improved appearance (P = 0.021). Testosterone was well tolerated in all patients.

Conclusions: Physiologic testosterone administration increases lean body mass and improves quality of life among androgen-deficient men with the AIDS wasting syndrome.


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Figure 1.
Flow of participants through the trial.

R = randomization.

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Figure 2.
Mean change ± SE for fat-free mass assessed by dual-energy x-ray absorptiometry, lean body mass determined from total-body potassium content, and muscle mass from urinary creatinine excretion in patients who received testosterone (left) and patients who received placebo (right) over 6 months.PPn

* < 0.05 for the change from baseline between the testosterone group and placebo group by analysis of covariance. **  <0.01 for the change from baseline between the testosterone group and placebo group by analysis of covariance. = number of patients for whom paired baseline and end-of-study data are available.

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