Preliminary evaluation of human immunodeficiency virus type 1 (HIV-1) immunogen in children with HIV-1 infection.
The safety and preliminary activity of human immunodeficiency virus type 1 (HIV-1) immunogen were evaluated in 10 HIV-1-infected children with disease stage N1,2 or A1,2. Multiple inoculations of 2. 5 or 10 units (U) of HIV-1 immunogen were safe and well tolerated without an acceleration of disease progression. When antiretroviral agents were coadministered, the 10 U dose appeared to be associated with more sustained reduction in plasma HIV-1 RNA than the 2.5 U dose (median log10 HIV-1 RNA at month 18, 3.07 vs. 4.01 copies/mL in 10 U [n=4] vs. 2.5 U [n=3], respectively; P=.034). Levels of regulated-on-activation, normal T cell-expressed and -secreted chemokine produced from HIV-1 immunogen-stimulated lymphocytes in vitro were increased in the children who had HIV-1 immunogen-specific antibody responses (P<.02) and appeared to be inversely correlated with levels of plasma HIV-1 RNA (P<.01). These preliminary data warrant larger studies to determine the effectiveness of adjunctive therapy with HIV-1 immunogen in children with HIV-1 infection.
Sei
S
S
HIV and AIDS Malignancy Branch, National Institutes of Health, Bethesda, Maryland, USA. SEI@dtpax2.nc
Sandelli
S L
SL
Theofan
G
G
Ratto-Kim
S
S
Kumagai
M
M
Loomis-Price
L D
LD
Cox
J H
JH
Jarosinski
P
P
Walsek
C M
CM
Brouwers
P
P
Venzon
D J
DJ
Xu
J
J
Pizzo
P A
PA
Moss
R B
RB
Robb
M L
ML
Wood
L V
LV
D016915:AIDS Vaccines / Q000009:adverse effects*; D000293:Adolescent; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D016049:Didanosine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000276:immunology* / Q000628:therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D012367:RNA, Viral / Q000097:blood; D012449:Safety; D013997:Time Factors; D015215:Zidovudine / Q000627:therapeutic use*
D016915:AIDS Vaccines; D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine; D016049:Didanosine