title: Low-dose growth hormone therapy reduces inflammation in HIV-infected patients: a randomized placebo-controlled study.
abstract: BACKGROUND
  Combination antiretroviral therapy (cART) has drastically increased the life expectancy of HIV-infected patients. However, HIV-infected patients exhibit increased inflammation and 33-58% exhibit a characteristic fat re-distribution termed HIV-associated lipodystrophy syndrome (HALS). Recombinant human growth hormone (rhGH) has been tested as treatment of HALS. Low-dose rhGH therapy improves thymopoiesis and fat distribution in HIV-infected patients and appears to be well tolerated. However, since high-dose rhGH is associated with adverse events related to inflammation, we wanted to investigate the impact of low-dose rhGH therapy on inflammation in HIV-infected patients.
  
  
  METHODS
  Forty-six cART-treated HIV-infected men were included in the HIV-GH low-dose (HIGH/Low) study: a randomized, placebo-controlled, double-blinded trial. Subjects were randomized 3:2 to 0.7 mg/day rhGH, or placebo for 40 weeks. rhGH was self-administered between 1 pm and 3 pm. The primary outcome of this substudy was changes in inflammation measured by plasma C-reactive protein (CRP) and soluble urokinase plasminogen activator receptor (suPAR).
  
  
  RESULTS
  Both CRP (-66%, p = 0.002) and suPAR (-9.7%, p = 0.06) decreased in the rhGH group compared to placebo; however, only CRP decreased significantly. The effect of rhGH on inflammation was not mediated through rhGH-induced changes in insulin-like growth factor 1, body composition, or immune parameters.
  
  
  CONCLUSIONS
  Daily 0.7 mg rhGH treatment for 40 weeks, administered at nadir endogenous GH secretion, significantly reduced CRP. The effect does not appear to be mediated by other factors. Our findings suggest that low-dose rhGH treatment may minimize long-term risks associated with high-dose rhGH therapy.
authors.affiliation: a Optimed, Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Johanne Bjerre
authors.initials: JB
authors.lastname: Lindboe
authors.affiliation: a Optimed, Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Anne
authors.initials: A
authors.lastname: Langkilde
authors.affiliation: b Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Jesper
authors.initials: J
authors.lastname: Eugen-Olsen
authors.affiliation: b Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;|c Department of Infectious Diseases , Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Birgitte R
authors.initials: BR
authors.lastname: Hansen
authors.affiliation: a Optimed, Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Haupt
authors.affiliation: a Optimed, Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;|d Department of Biostatistics , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Janne
authors.initials: J
authors.lastname: Petersen
authors.affiliation: a Optimed, Clinical Research Centre 056, Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;|c Department of Infectious Diseases , Copenhagen University Hospital Hvidovre , Hvidovre , Denmark ;
authors.forename: Ove
authors.initials: O
authors.lastname: Andersen
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage; D002097:C-Reactive Protein / Q000032:analysis; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D013006:Growth Hormone / Q000008:administration & dosage*; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007249:Inflammation / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D055293:Receptors, Urokinase Plasminogen Activator / Q000097:blood; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D010919:Placebos; D055293:Receptors, Urokinase Plasminogen Activator; D013006:Growth Hormone; D002097:C-Reactive Protein
keywords: CRP; IGF-1; lipodystrophy; suPAR