title: Preliminary evaluation of human immunodeficiency virus type 1 (HIV-1) immunogen in children with HIV-1 infection.
abstract: 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.
authors.affiliation: HIV and AIDS Malignancy Branch, National Institutes of Health, Bethesda, Maryland, USA. SEI@dtpax2.nc
authors.forename: S
authors.initials: S
authors.lastname: Sei
authors.forename: S L
authors.initials: SL
authors.lastname: Sandelli
authors.forename: G
authors.initials: G
authors.lastname: Theofan
authors.forename: S
authors.initials: S
authors.lastname: Ratto-Kim
authors.forename: M
authors.initials: M
authors.lastname: Kumagai
authors.forename: L D
authors.initials: LD
authors.lastname: Loomis-Price
authors.forename: J H
authors.initials: JH
authors.lastname: Cox
authors.forename: P
authors.initials: P
authors.lastname: Jarosinski
authors.forename: C M
authors.initials: CM
authors.lastname: Walsek
authors.forename: P
authors.initials: P
authors.lastname: Brouwers
authors.forename: D J
authors.initials: DJ
authors.lastname: Venzon
authors.forename: J
authors.initials: J
authors.lastname: Xu
authors.forename: P A
authors.initials: PA
authors.lastname: Pizzo
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
authors.forename: M L
authors.initials: ML
authors.lastname: Robb
authors.forename: L V
authors.initials: LV
authors.lastname: Wood
mesh_terms: 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*
chemical_list: D016915:AIDS Vaccines; D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine; D016049:Didanosine