title: Treatment with recombinant growth hormone is associated with modest improvement in CD4 lymphocyte reconstitution in HIV-infected persons on antiretroviral therapy: results of ACTG A5174.
abstract: Pilot studies have suggested that treatment with recombinant human growth hormone (rhGH) is associated with increased T-lymphocyte restoration and enhanced thymic output. We evaluated the immunologic effects of rhGH on HIV(+) subjects with incomplete immune reconstitution on antiretroviral therapy (ART). Sixty subjects were randomized to receive rhGH 1.5 mg scqd and ART for 48 weeks (Arm A) or continue ART alone for 24 weeks then add rhGH 3.0 mg scqd for 24 weeks (Arm B). Median baseline CD4 for Arms A and B were 223 and 219, respectively. There was little difference between Arm A and Arm B in change in total or naive CD4 cells or percentage from baseline to week 24. Only one subject in Arm A met the primary endpoint, an increase in naive CD4 percentage of at least 10 percentage points. By week 48 both Arms had statistically significant increases in naive CD4 cell count and percentage and thymus size. Within Arm B, treatment with rhGH was associated with significant increases in naive CD4(+) cell count and percentage compared with ART alone. Treatment with rhGH +ART may be associated with modest increases in CD4 lymphocytes over ART alone in subjects with CD4 <350, yet the origin of these naive cells and their impact on immune function require further investigation.
authors.affiliation: Section of Infectious Diseases, Rush University Medical Center, Chicago, Illinois 60612, USA. ksmith2@rush.edu
authors.forename: Kimberly
authors.initials: K
authors.lastname: Smith
authors.forename: Lu
authors.initials: L
authors.lastname: Zheng
authors.forename: Ronald
authors.initials: R
authors.lastname: Bosch
authors.forename: David M
authors.initials: DM
authors.lastname: Margolis
authors.forename: Allan
authors.initials: A
authors.lastname: Tenorio
authors.forename: Laura
authors.initials: L
authors.lastname: Napolitano
authors.forename: Michael
authors.initials: M
authors.lastname: Saag
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Connick
authors.forename: Barry
authors.initials: B
authors.lastname: Gross
authors.forename: Isaac
authors.initials: I
authors.lastname: Francis
authors.forename: Hernan
authors.initials: H
authors.lastname: Valdez
authors.forename: Norma
authors.initials: N
authors.lastname: Muurahainen
authors.forename: Vicky
authors.initials: V
authors.lastname: Stocker
authors.forename: Richard
authors.initials: R
authors.lastname: Pollard
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects*; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D015497:HIV-1; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000187:drug effects; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D016176:T-Lymphocyte Subsets / Q000187:drug effects; D013950:Thymus Gland / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents; D011994:Recombinant Proteins; D019382:Human Growth Hormone