title: Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy.
abstract: HIV-associated wasting is defined as > or = 10% involuntary weight loss and includes declines in both lean and fat mass. This large (757 subjects), randomized, double-blind, placebo-controlled trial investigated the efficacy, safety, and tolerability of recombinant human growth hormone (rhGH) in 2 doses-0.1 mg/kg up to a maximum of 6 mg daily (DD) or alternate days (AD)-in the treatment of wasting and weight loss in highly active antiretroviral therapy (HAART)-treated HIV-infected subjects. The evaluable population for ergometry comprised 555 subjects, 87.6% of whom were receiving HAART. At 12 weeks, median maximum work output increased by 2.4 and 2.6 kJ in the AD and DD groups, respectively. The median treatment difference was 2.9 kJ for DD vs. placebo (P < 0.0001). Body weight increased by 2.2 and 2.9 kg in the AD and DD groups, respectively. Corresponding median treatment differences vs. placebo were 1.5 and 2.2 kg (P < 0.0001). Lean body mass (LBM), by bioelectric impedance spectroscopy, increased by 3.3 and 5.2 kg, respectively (P < 0.0001 vs. placebo; P = 0.0173 DD vs. AD), and fat mass, predominately truncal, decreased. Quality of life (QoL) improved significantly in both rhGH groups. Fluid-retention adverse effects and hyperglycemia were more common in the DD than in the AD group. No significant changes in HIV viral load or CD4 cell count occurred. In conclusion, over the 12-week course of therapy, rhGH, 0.1 mg/kg DD, was superior to placebo in improving physical function, body weight, body composition, and QoL and was superior to AD dosing in restoring LBM.
authors.affiliation: HIV Research and HIV/GU Medicine Department, Chelsea and Westminster Hospital, London, UK.
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Moyle
authors.forename: Eric S
authors.initials: ES
authors.lastname: Daar
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Gertner
authors.forename: Donald P
authors.initials: DP
authors.lastname: Kotler
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Melchior
authors.forename: Fanny
authors.initials: F
authors.lastname: O'brien
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Svanberg
mesh_terms: D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D001823:Body Composition / Q000187:drug effects; D004334:Drug Administration Schedule; D017079:Exercise Tolerance / Q000187:drug effects*; D005260:Female; D019247:HIV Wasting Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D015430:Weight Gain / Q000187:drug effects
chemical_list: D011994:Recombinant Proteins; D019382:Human Growth Hormone