Pilot study of the immunologic effects of recombinant human growth hormone and recombinant insulin-like growth factor in HIV-infected patients.
OBJECTIVE
To study the immunologic effects of recombinant human growth hormone (rhGH), recombinant human insulin-like growth factor type 1 (rhIGF-1), or the combination, in patients with moderately advanced HIV infection.


METHODS
Randomized but not blinded trial.


METHODS
Government medical research center.


METHODS
Twenty-four HIV-infected patients with CD4 cell counts of 100-400 x 10(6)/l who were receiving nucleoside antiretroviral therapy.


METHODS
Either rhGH, rhIGF-1, or the combination was administered subcutaneously for 12 weeks.


METHODS
Immunologic parameters, including T-cell subsets and assays of in vitro interleukin (IL)-2 production in response to antigens and mitogens, and safety profile.


RESULTS
Plasma IGF-1 levels were low or low-normal prior to treatment and increased with all three therapies. There were no significant changes in CD4 cell counts, RA/RO CD4 cell subsets, natural killer cell function, immunoglobulin levels, or in vitro IL-2 production in response to mitogen or alloantigens. However, there was an upward trend (and for p18IIIB a statistically significant increase) in the in vitro IL-2 production in response to each of five HIV envelope peptides. Potential toxic effects included fatigue, arthralgia, edema, myalgia, and headache. Patients also were noted to have weight gain averaging 4 kg early in the course of treatment.


CONCLUSIONS
These results suggest that treatment with rhGH/rhIGF-1 was reasonably well tolerated and that modest improvement in HIV-specific immune function was attained. Further studies will help clarify the therapeutic potential of rhGH/rhIGF-1 as an immunostimulator in the setting of HIV infection.
Nguyen
B Y
BY
HIV and AIDS Malignancy Branch, National Cancer Institute (NCI), National Institutes of Health, Bethesda 20892-1906, USA.
Clerici
M
M
Venzon
D J
DJ
Bauza
S
S
Murphy
W J
WJ
Longo
D L
DL
Baseler
M
M
Gesundheit
N
N
Broder
S
S
Shearer
G
G
Yarchoan
R
R
D000328:Adult; D001835:Body Weight; D018791:CD4 Lymphocyte Count; D005260:Female; D016655:HIV Core Protein p24 / Q000097:blood; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D007136:Immunoglobulins / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000009:adverse effects / Q000032:analysis / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000096:biosynthesis; D007694:Killer Cells, Natural / Q000276:immunology; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D016176:T-Lymphocyte Subsets / Q000276:immunology; D006377:T-Lymphocytes, Helper-Inducer / Q000502:physiology
D016655:HIV Core Protein p24; D007136:Immunoglobulins; D007376:Interleukin-2; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I