Effects of nandrolone decanoate compared with placebo or testosterone on HIV-associated wasting

J. Gold, Marijka J. Batterham*, H. Rekers, M. K. Harms, T. B.P. Geurts, P. M.E. Helmyr, J. Silva de Mendonça, L. H.Falleiros Carvalho, G. Panos, A. Pinchera, F. Aiuti, C. Lee, A. Horban, J. Gatell, P. Phanuphak, W. Prasithsirikul, B. Gazzard, M. Bloch, S. A. Danner

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objectives: Current research is unclear about the most effective pharmacological agents for managing the loss of weight and fat-free mass common in HIV/AIDS. The aim of this study was to compare nandrolone decanoate with placebo and testosterone. Methods: The study was a multicentre randomized double-blind placebo-controlled trial. Three hundred and three adult HIV-positive male patients with a weight loss of 5-15% in the last 12 months, or a body mass index of 17-19 kg/m2, or a body cell mass/height ratio lower than 13.5 kg/m, were randomly assigned to receive nandrolone decanoate (150 mg), testosterone (250 mg) or placebo intramuscularly every 2 weeks for 12 weeks. Fat-free mass, weigth, immune markers and perception of treatment were the main outcome measures. Results: Treatment with nandrolone resulted in significantly greater increases in fat-free mass [mean increase 1.34 kg; 95% confidence interval (CI) 0.60; 2.08 kg] and in weight (mean increase 1.48 kg; 95% CI 0.82; 2.14 kg) compared with placebo. The mean increase in weight with nandrolone of 1.00 kg (95% CI 0.27; 1.74 kg) when compared with testosterone was significant, although the difference in fat free mass did not reach significance (mean increase 0.69 kg; 95% CI-0.13; 1.51 kg). Patient perception of benefit was significantly greater in the nandrolone group when compared with both the placebo and the testosterone groups. Conclusion: Treatment with nandrolone decanoate increased body weight when compared with placebo and testosterone. Nandrolone decanoate treatment resulted in greater increases in fat-free mass than placebo and demonstrated a trend for a significant increase when compared with testosterone.

Original languageEnglish
Pages (from-to)146-155
Number of pages10
JournalHIV Medicine
Volume7
Issue number3
DOIs
Publication statusPublished - Apr 2006

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