Preliminary Evaluation of Human Immunodeficiency Virus Type 1 (HIV-1) Immunogen in Children with HIV-1 Infection

• Published in: The Journal of infectious diseases 1999-09, Vol.180 (3), p.626-640
• Main Authors: Sei, Shizuko, Sandelli, Susan L., Theofan, Georgia, Ratto-Kim, Silvia, Kumagai, Mutsuko, Loomis-Price, Lawrence D., Cox, Josephine H., Jarosinski, Paul, Walsek, Claire M., Brouwers, Pim, Venzon, David J., Xu, Jing, Pizzo, Philip A., Moss, Ronald B., Robb, Merlin L., Wood, Lauren V.
• Format: Article
• Language: English
• Subjects: Adolescent; AIDS; AIDS Vaccines - adverse effects; AIDS/HIV; Anti-HIV Agents - therapeutic use; Antigens; Antiretrovirals; Biological and medical sciences; Child; Child, Preschool; Combined Modality Therapy; Didanosine - therapeutic use; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; HIV; HIV 1; HIV Infections - immunology; HIV Infections - therapy; HIV-1 - isolation & purification; Human immunodeficiency virus 1; Human viral diseases; Humans; immunogens; Infant; Infections; Infectious diseases; Inoculation; Lymphocytes; Major Articles; Male; Medical sciences; Microbiology; RNA; RNA, Viral - blood; Safety; T lymphocytes; Time Factors; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Virology; Zidovudine - therapeutic use
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/314944

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.