Document 0089
 DOCN  M9470089
 TI    Effect of immunization with inactivated gp120-depleted human
       immunodeficiency virus type 1 (HIV-1) immunogen on HIV-1 immunity, viral
       DNA, and percentage of CD4 cells.
 DT    9409
 AU    Trauger RJ; Ferre F; Daigle AE; Jensen FC; Moss RB; Mueller SH; Richieri
       SP; Slade HB; Carlo DJ; Immune Response Corporation, Carlsbad,
       California 92008.
 SO    J Infect Dis. 1994 Jun;169(6):1256-64. Unique Identifier : AIDSLINE
       MED/94253583
 AB    A 1-year study measured the effect of administration of an inactivated
       human immunodeficiency virus type 1 (HIV-1) immunogen in incomplete
       Freund's adjuvant (IFA) on HIV-1-specific immunity and viral burden in
       asymptomatic HIV-1-infected patients. A total of 103 patients were
       enrolled in this double-blind, randomized study comparing immunogen in
       adjuvant with adjuvant alone. This study was conducted at nine medical
       centers throughout the United States. Significant differences in
       cell-mediated immune responses to HIV-1 and p24 core antigen were
       observed between the treated and control groups (P < .01). Compared with
       controls, treated patients as a group had a significantly lower rate of
       increase in viral DNA as determined by quantitative HIV-1 DNA-polymerase
       chain reaction (P = .016). Significant differences in the rate of
       percent CD4 cell decline were also observed between the 2 groups (P =
       .024). These data suggest that augmentation of HIV-1-specific immunity
       via immunotherapy may alter the rate of increase of HIV-1 DNA in
       peripheral blood mononuclear cells and stabilize the percent of CD4 cell
       decline in relatively healthy HIV-1-infected persons.
 DE    Adolescence  Adult  Antibody Formation  AIDS Vaccines/ADMINISTRATION &
       DOSAGE/*IMMUNOLOGY  Double-Blind Method  DNA, Viral/ANALYSIS  Freund's
       Adjuvant  Human  HIV Antibodies/IMMUNOLOGY  HIV Envelope Protein
       gp120/*IMMUNOLOGY  HIV-1/*IMMUNOLOGY  Immunity, Cellular/IMMUNOLOGY
       Leukocyte Count  Leukocytes, Mononuclear/MICROBIOLOGY  Middle Age  T4
       Lymphocytes/CYTOLOGY/*IMMUNOLOGY  Vaccination  Vaccines,
       Inactivated/ADMINISTRATION & DOSAGE/IMMUNOLOGY  CLINICAL TRIAL  JOURNAL
       ARTICLE  RANDOMIZED CONTROLLED TRIAL

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