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A Randomized, Placebo-Controlled Trial of Nandrolone Decanoate in Human Immunodeficiency Virus-Infected Men with Mild to Moderate Weight Loss with Recombinant Human Growth Hormone as Active Reference Treatment

Division of Endocrinology, Metabolism, and Molecular Medicine (T.W.S., L.J.W., A.B.S., M.P., P.M., S.B.), Charles R. Drew University of Medicine and Science, Los Angeles, California 90059; Laboratory for Exercise Science (T.W.S.), El Camino College, Torrance, California 90506; Departments of Medicine and Biokinesiology and Physical Therapy (F.S., E.T.S.), Keck School of Medicine, University of Southern California, Los Angeles, California 90033; Division of Allergy and Immunology (K.B.), Harbor-University of California Los Angeles Medical Center, Torrance, California 90502; Division of Endocrinology, Metabolism, and Lipid Research (K.E.Y.), Washington University School of Medicine, St. Louis, Missouri 63110; and International Medical Services (P.G., M.K.H.) and Clinical Trials Operations-Biometrics (A.W.), Organon, 5340 BH Oss, The Netherlands

Address all correspondence and requests for reprints to: Thomas W. Storer, Ph.D., Professor of Medicine, University of California, Los Angeles School of Medicine, Director, Laboratory of Exercise Sciences, El Camino College, Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California 90059. E-mail: tstorer{at}elcamino.edu.

Objective: We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH.

Methods: In this placebo-controlled, randomized, 12-wk trial, placebo and nandrolone (150 mg im biweekly) were administered double blind, and rhGH (6 mg sc daily) was administered in an open-label manner. Participants were HIV-infected men with 5–15% weight loss over 6 months and on stable antiretroviral therapy for more than 12 wk. Lean body mass (LBM), muscle performance, physical function, endurance, hormone levels, insulin sensitivity, sexual function, quality of life, and appetite were assessed at baseline and after 12 wk.

Results: Nandrolone administration was associated with a greater increase in LBM (+1.6 ± 0.3 kg) by dual-energy x-ray absorptiometry scan than placebo (+0.4 ± 0.3 kg; P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 ± 0.3 kg). Nandrolone administration was also associated with significantly greater gains in fat-free mass (+1.6 ± 0.3 kg), body cell mass (+1.0 ± 0.2 kg), and intracellular water (+0.9 ± 0.2 kg) than placebo; these changes in the nandrolone group were not significantly different from the rhGH group. rhGH administration was associated with greater loss of whole body fat mass and higher frequency of drug-related adverse effects and treatment discontinuations than nandrolone and placebo and a greater increase in extracellular water than nandrolone. Nandrolone treatment was associated with greater improvements in perception of health than rhGH and sexual function than placebo. The cachexia/anorexia scores, health care resource use, and insulin sensitivity did not significantly change.

Conclusion: We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.

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