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A Randomized, Double-blind, Placebo-Controlled, Multicenter Trial

Kathleen Mulligan, PhD; Robert Zackin, ScD; Rebecca A. Clark, MD, PhD; Beverly Alston-Smith, MD; Tun Liu, MS; Fred R. Sattler, MD; Thomas B. Delvers, RPh; Judith S. Currier, MD, MSc; for the AIDS Clinical Trials Group 329 Study Team and the National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group

Arch Intern Med. 2005;165:578-585.

Background  Weight loss is associated with accelerated mortality and disease progression in patients with human immunodeficiency virus (HIV) infection. Although studies have examined a variety of anabolic therapies in HIV-infected men, the safety and efficacy of such treatments in women have not been adequately studied.

Methods  In this randomized, double-blind, placebo-controlled, multicenter, phase I/II study, 38 HIV-infected women with documented weight loss of 5% or greater in the preceding year or a body mass index of less than 20 kg/m² were randomized to receive nandrolone decanoate (100 mg) or an equivalent volume of placebo every other week by intramuscular injection. Subjects received blinded treatment for 12 weeks, followed by open-label therapy for 12 weeks. Lean body mass and fat (bioelectrical impedance analysis) and weight were measured at baseline and at weeks 6, 12, 18, and 24. Biochemical assessments of safety (hematologic analyses, liver function tests, and sex hormone measurements) were performed at these same time points. Clinical signs and symptoms were monitored biweekly.

Results  Subjects randomized to receive nandrolone had significant increases in weight and lean body mass during blinded treatment (4.6 kg [9.0%] and 3.5 kg [8.6%], respectively; P<.001 vs baseline and placebo in each case). Fat mass did not change statistically significantly in either group. Although there were no statistically significant differences between groups in biochemical measures, the number of grade 3 or greater toxicities, or reports of virilizing effects, a full assessment of safety cannot be made in a trial of this size.

Conclusion  Nandrolone decanoate therapy may prove to be generally safe and beneficial in reversing weight loss and lean tissue loss in women with HIV infection and other chronic catabolic diseases.

Author Affiliations: Department of Medicine, University of California, San Francisco, and Division of Endocrinology, San Francisco General Hospital (Dr Mulligan); Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Mass (Dr Zackin and Mr Liu); Louisiana State University Health Science Center, New Orleans (Dr Clark); National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md (Dr Alston-Smith); Department of Medicine, Division of Infectious Diseases, Keck School of Medicine, University of Southern California, Los Angeles (Dr Sattler); Organon Pharmaceuticals USA Inc, Roseland, NJ (Mr Delvers); and Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles (Dr Currier).
Deceased.

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