Seventh International Congress on Drug Therapy in HIV Infection Glasgow, UK - 14-17 November 2004

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL7.5

Julian Gold¹ , Marijka Batterham¹, Peggy M.E. Helmyr³, Marloes Harms ³, Hans Rekers^3
1Albion St Centre, Prince of Wales Hospital, Sydney; ²University of Wollongong, Wollongong, Australia; ³Medical Services, Organon International, Oss, The Netherlands

Loss of weight and fat free mass (FFM) remain common problems in people with HIV/AIDS. The expense and problems of administering human growth hormone and the side effects of some oral anabolic agents increase the imperative to find low cost and effective therapeutic approaches, especially for patients who are also hypogonadal.

This study was an international multi-center RDBPC trial comparing nandrolone decanoate (ND) with placebo and testosterone (T).

Three hundred and three (303) adult HIV positive males with a weight loss of 5-15% in the last 12 months, or a body mass index of 17-19kg/m², or a body cell mass/height ratio lower than 13.5kg/m were randomized to ND (150mg), T (250mg) or placebo, fortnightly for 12 weeks.Outcomes were assessed using anthropometry, BIA and biochemical and immunological parameters, including gonadal function.

Treatment with ND resulted in a significantly greater increase in FFM of 1.34kg (95%CI 0.60;2.08kg) and weight 1.48kg (0.82;2.14kg) versus placebo. Increases in weight were significantly greater with ND versus T 1.00kg (0.27;1.74) and in QOL: the difference in FFM did not reach significance 0.69kg (-0.13;1.51kg). There were no significant differences in adverse events, in immune markers or HIV viral load.

This is the first multi-centre clinical trial of its type which provides important evidence to assist clinicians to manage patients with HIV wasting. Treatment with ND increases body weight when compared with placebo and T. ND treatment results in greater increases in FFM than placebo and demonstrates a trend to a significant increase when compared with T.

SESSION 7: ADVERSE EVENTS I

2004-11-14
PL7.5

Copyright © 2004 - Thomson ACUMED® All rights reserved. Thomson ACUMED® is an intelligent and innovative medical marketing and communications agency – a new division of The Gardiner-Caldwell Group Ltd, part of The Thomson Corporation, located in Tytherington, UK.

Reproduction of this abstract (other than one copy for personal reference) must be cleared through the authors.

This information is designed to support, not replace, the relationship that exists between you and your doctor. ©1980, 2005. AEGiS.