Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Background: Wasting with lean body mass (LBM) loss is a major complication in AIDS. Although prevalence has fallen, wasting remains a chronic debilitating, life-threatening condition.

The effect of r-hGH on AIDS associated wasting in an HIV positive population with access to HAART was, therefore, evaluated.

Methods: Patients with 10% weight loss, body mass index <20, or weight <90% ideal body weight were randomized (1:1:1) in this double-blind, placebo-controlled, multi-centre study to 12 weeks therapy with r-hGH 6mg daily (DD), 6 mg alternate days (AD), or placebo (P). Physical performance was assessed by cycle ergometry, LBM by bioimpedance spectroscopy (BIS) and dual energy X-ray absorptiometry (DXA), and quality of life by BACRI and MHSA questionnaires.

Results: 757 (247P, 253DD, 257AD) subjects began and 646 (226P, 201DD, 219AD) completed the study. Subjects were white (77%) men (91%), mean age 41 years, 88% of whom were on HAART. Over the 12 weeks there was a treatment effect in cycle ergometry performance of y 2.85kJ (p<0.001 vs P). LBM (by BIS) increased by 4.6kg in DD and 2.7kg in AD (both p<0.0001 vs P); DXA yielded similar findings. Total and trunk fat mass (by DXA) decreased 1.4kg and 1.1kg, respectively, in DD, 1.2kg and 0.7kg in AD (all p<0.0001 vs P). Net increase in body weight was 2.2kg (DD), and 1.5kg (AD) (p<0.0001 vs P). Treatment satisfaction scores (patient answers to BACRI question 7: “Do you think this treatment has been of benefit to you?”) gave mean values of 51.6 in P, 72.3 in DD, 65.4 in AD (p<0.001 vs P). Statistical analysis was a repeated measures ANOVA with effects for treatment, pooled centre, time and treatment-by-time interaction. Statistical differences persisted when intent-to-treat analysis was performed. Viral load did not change over 12 weeks. Patients withdrew due to toxicity (0.9%), adverse events, principally limb pains (2.1%), patient decision (5.4%) or other causes (6.3%).

Conclusions: r-hGH treatment was well tolerated. Twelve weeks of treatment significantly improved physical performance. There were dose dependent improvements in LBM and quality of life in these HIV positive patients with wasting in the presence of HAART.

Presenting author: Graeme Moyle

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1 Chelsea and Westminster Hospital, London, United Kingdom

2 Cedars-Sinai Medical Center, Los Angeles, USA

3 Serono Inc., Rockland, USA

4 St Luke’s Roosvelt Hospital, New York, USA

5 Hôpital Raymond Poincare, Garches, France

6 Serono International, Geneva, Switzerland

2002-11-17
PL12-3

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