title: 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.
abstract: 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.
authors.affiliation: Immune Response Corporation, Carlsbad, California 92008.
authors.forename: R J
authors.initials: RJ
authors.lastname: Trauger
authors.forename: F
authors.initials: F
authors.lastname: Ferre
authors.forename: A E
authors.initials: AE
authors.lastname: Daigle
authors.forename: F C
authors.initials: FC
authors.lastname: Jensen
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
authors.forename: S H
authors.initials: SH
authors.lastname: Mueller
authors.forename: S P
authors.initials: SP
authors.lastname: Richieri
authors.forename: H B
authors.initials: HB
authors.lastname: Slade
authors.forename: D J
authors.initials: DJ
authors.lastname: Carlo
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D000917:Antibody Formation; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology / Q000276:immunology*; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D005620:Freund's Adjuvant; D015483:HIV Antibodies / Q000276:immunology; D015699:HIV Envelope Protein gp120 / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007958:Leukocyte Count; D007963:Leukocytes, Mononuclear / Q000382:microbiology; D008875:Middle Aged; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; D004279:DNA, Viral; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; D015164:Vaccines, Inactivated; D005620:Freund's Adjuvant