AEGiS-Glasgow [PL7.6] The effects of nandrolone decanoate on weight loss and quality of life in male patients with acquired immunodeficiency syndrome

Seventh International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 14-17 November 2004

[PL7.6] The effects of nandrolone decanoate on weight loss and quality of life in male patients with acquired immunodeficiency syndrome

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL7.6

Chris J. Duncombe , Theshinee Chuenyam , Paul T. Geurts , Marloes K. Harms , Praphan Phanuphak
1HIV-NAT, The Netherlands Australia Thailand Research Collaboration, Thailand, Bangkok; 2Int. Med. Service, Organon, Oss, The Netherlands

This study examined the effects of nandrolone decanoate (ND) on lean body mass (LBM), body weight, quality of life and immune function in subjects with HIV wasting.

This was a multi-center, randomized, double blind, placebo controlled study of the effects of 24 weeks of treatment with ND in three different doses in the prevention or delay of weight loss and on quality of life in HIV-infected male patients. Subjects with 5-15% weight loss, stable on antiretroviral therapy for a minimum of eight weeks or on no antiretroviral therapy, were randomized to receive ND 50 mg, 100 mg or 150 mg by intramuscular injection once every two weeks or placebo. Efficacy was assessed by mean changes in body weight, LBM and anthropometry. Quality of life was measured using the MOS-SF30 questionnaire.

91 subjects were included in the intention to treat analysis. In the ND 150 mg and 100 mg groups, there was a mean increase in LBM from baseline to week 12 and from baseline to week 24 compared to placebo (p<0.05). At week 12 (primary efficacy endpoint), the changes in LBM for subjects receiving placebo or nandrolone decanoate 50mg, 100mg or 150mg were -0.81 kg, -0.13 kg, +0.59 kg and +0.76 kg respectively. There was an increase in mean body weight at week 12 in the ND 150 mg group (+ 0.55 kg), compared to placebo (-1.42 kg) (p<0.05). No dose-related responses were observed in change of quality of life or in CD4 and CD8 cell counts. ND was well tolerated. 15 subjects discontinued the trial due to an adverse event. None of these events were considered to be study drug-related by the investigator

ND was safe and resulted in increases in body weight and LBM at weeks 12 and 24

SESSION 7: ADVERSE EVENTS I

2004-11-14
PL7.6

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