title: Recombinant human growth hormone, insulin-like growth factor 1, and combination therapy in AIDS-associated wasting. A randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To increase lean body mass and improve health status in patients with wasting associated with the acquired immunodeficiency syndrome (AIDS) by treatment with recombinant human growth hormone (rhGH), recombinant human insulin-like growth factor 1 (rhIGF-1), or both.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled clinical trial.
  
  
  METHODS
  University of New Mexico Clinical Research Center and University of Texas Southwestern Medical Center.
  
  
  METHODS
  60 patients with AIDS and wasting as defined by the Centers for Disease Control and Prevention. Patients were divided into four groups of 15 patients each.
  
  
  METHODS
  Group 1 received 1.4 mg of rhGH once daily plus placebo twice daily; group 2 received 5 mg of rhIGF-1 twice daily plus placebo once daily; group 3 received 5 mg of rhIGF-1 twice daily plus 1.4 mg of rhGH once daily; and group 4 received placebo three times daily.
  
  
  METHODS
  Body weight, body composition, muscle strength, protein catabolism, quality of life, and immune status were assessed at baseline, and changes in these variables were measured at 6 and 12 weeks.
  
  
  RESULTS
  At 6 weeks, lean body mass had increased and total fat mass had decreased in the groups receiving rhGH, rhIGF-1, or both. Group 3 had the greatest changes in lean body mass (mean +/- SE, 3.2 +/- 0.59 kg; P < 0.001); only in this group were changes in body mass maintained at 12 weeks. Only patients in group 1 had improvement in muscular strength of the knees and upper body (P = 0.04) and quality of life (P = 0.01). Immunologic function did not improve in any group.
  
  
  CONCLUSIONS
  Growth factor therapy had significantly increased lean body mass and decreased fat mass by 6 weeks, but these improvements persisted for 12 weeks only in group 3. Growth factor therapy at the dosages used in this study is not recommended because the magnitude of weight gain was modest and improvements in quality-of-life measures varied.
authors.affiliation: Department of Medicine/Endocrinology, University of New Mexico School of Medicine, Albuquerque 87131-5271, USA.
authors.forename: D
authors.initials: D
authors.lastname: Waters
authors.forename: J
authors.initials: J
authors.lastname: Danska
authors.forename: K
authors.initials: K
authors.lastname: Hardy
authors.forename: F
authors.initials: F
authors.lastname: Koster
authors.forename: C
authors.initials: C
authors.lastname: Qualls
authors.forename: D
authors.initials: D
authors.lastname: Nickell
authors.forename: S
authors.initials: S
authors.lastname: Nightingale
authors.forename: N
authors.initials: N
authors.lastname: Gesundheit
authors.forename: D
authors.initials: D
authors.lastname: Watson
authors.forename: D
authors.initials: D
authors.lastname: Schade
mesh_terms: D000328:Adult; D001823:Body Composition; D001834:Body Water / Q000502:physiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D019247:HIV Wasting Syndrome / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000503:physiopathology; D010352:Patient Dropouts; D010919:Placebos; D011506:Proteins / Q000378:metabolism; D011788:Quality of Life; D015430:Weight Gain
chemical_list: D010919:Placebos; D011506:Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I