AEGiS-14IAC: Recombinant Human Growth Hormone is effective to treat HIV/AIDS associated wasting in the era of Highly Active Anti-Retroviral Therapy.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Recombinant Human Growth Hormone is effective to treat HIV/AIDS associated wasting in the era of Highly Active Anti-Retroviral Therapy.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeB9012)

Daar E, Gertner J, Kotler D, Melchior JC, Moyle G, O'Brien F, Svanberg E
Cedars-Sinai Health Sciences, Los Angeles, United States

Wasting with lean body mass (LBM) loss is a major complication in AIDS for which r-hGH (Serostim é «) was approved before the introduction of HAART. Since then prevalence has fallen, but it remains a chronic debilitating, life threatening condition. The aim of this study was to evaluate the effect of r-hGH for the treatment of AIDS wasting in an HIV+ population with access to HAART.

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-center 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 started and 646 (226P, 201DD, 219AD) completed 12 weeks. Subjects were white (77%) men (91%), mean age 41 years. 85% were on HAART. Over 12 weeks cycle ergometry performance increased by 2.60kJ in DD (p<0.001 vs P) and 2.35kJ in AD. LBM (by BIS) increased by 4.6kg in DD and 2.7kg in AD (both p<0.0001 vs P), DXA data were similar. 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 (Q7 on BACRI) were 51.6 in P, 72.3 in DD, 65.4 in AD (p<0.001 vs P). Statistical differences persisted when intent-to-treat analysis was performed. Viral load did not change over 12 weeks. Patient withdrawal was due to toxicity (0.9%), adverse events, principally limb pains (2.1%), patient decision (5.4%) or other causes (6.3%).

CONCLUSIONS: r-hGH (Serostim é «) treatment was safe and well tolerated. It was effective in improving physical performance, increasing LBM and improving quality of life in HIV+ with wasting in the era of HAART.

Keywords: AEGIS, Acquired Immunodeficiency Syndrome, Human Growth Hormone, HIV Infections, Densitometry, X-Ray, Body Composition, HIV Seropositivity, Antiretroviral Therapy, Highly Active, Viral Load, Body Weight, Body Mass Index, Placebos, Human, Male, therapy, radiography, drug therapy

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LbPeB9012