Moyle G, Kotler D, Gertner J, Daar E, Melchior JC, O'Brien F, Svanberg E; IAS Conference on HIV Pathogenesis and Treatment (2nd : 2003 : Paris, France).
Antivir Ther. 2003; 8 (Suppl.1): abstract no. 719.
1 St Luke's Roosevelt Hospital, New York, USA
OBJECTIVE: Aims of this study were to confirm clinical efficacy and to establish optimal dose for r-hGH (SerostimO) in HIV wasting in the HAART era. METHODS: Patients with 10% weight loss, BMI <20, or weight <90% ideal body weight were randomized (1:1:1) in a 12 week double blind placebo controlled study of r-hGH 6 mg daily (DD), 6 mg alternate days (AD), or placebo (P). At baseline and after treatment, body composition was assessed by dual energy X-ray absorptiometry (DXA). 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. 90% were on HAART. At baseline, median BMI and body weight were 20.8 kg/m2 and 65.5 kg respectively. Median LBM and total body fat were 52.76 kg and 8.26 kg respectively. LBM increased by 3.44 kg in DD and 2.62 kg in AD (both P<0.0001 vs P). Total and trunk fat mass decreased 1.4 kg and 1.1 kg respectively in DD, 1.2 kg and 0.8 kg in AD (all P<0.0001 vs P). Net increase in body weight was significant in both arms. Viral load remained stable. 6 mg r-hGH AD was slightly better tolerated with fewer adverse events (related to fluid retention, interstitial fluid redistribution and glucose homeostasis) than 6 mg DD. CONCLUSION: r-hGH (SerostimO), 6 mg DD was superior to 6 mg AD on body weight and body composition of HIV wasting patients in the HAART era. 6 mg AD was slightly better tolerated than 6 mg DD.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Antiretroviral Therapy, Highly Active
- Body Composition
- Body Weight
- HIV Infections
- HIV Seropositivity
- Human Growth Hormone
- Humans
- Male
- Nutritional Status
- Placebos
- Viral Load
- Weight Loss
Other ID:
UI: 102262998
From Meeting Abstracts