title: Viral load, CD4 percentage, and delayed-type hypersensitivity in subjects receiving the HIV-1 immunogen and antiviral drug therapy.
abstract: Two trials of subjects inoculated with the inactivated, gp120-depleted HIV-1 Immunogen are reported. In one study, in which 19 subjects received ZDV and 8 subjects received ddI, treatment with the HIV-1 Immunogen did not affect the pharmacokinetic parameters of the antiviral drugs. In another study, 65 subjects who were previously immunized with the HIV-1 Immunogen over a mean period of 4.0 years (range, 1.2-5.4 years) received inoculations at 0 and 6 months. At some point during this 48-week study, 72% of the subjects (47/65) were receiving antiviral drug therapy. The HIV-1 DNA load in CD4 cells and CD4 percentage were found to be stable over the 48-week period. Delayed-type hypersensitivity to HIV-1 antigens increased after two inoculations with the HIV-1 Immunogen. In these two trials, no serious treatment-related adverse events were documented in the subjects. The two studies presented herein are the first to suggest that an immune-based therapy such as the HIV-1 Immunogen can be combined safely with antiviral drugs, supporting further study to evaluate the clinical utility of this approach.
authors.affiliation: Immune Response Corporation, Carlsbad, California 92008, USA.
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
authors.forename: F
authors.initials: F
authors.lastname: Ferre
authors.forename: A
authors.initials: A
authors.lastname: Levine
authors.forename: J
authors.initials: J
authors.lastname: Turner
authors.forename: F C
authors.initials: FC
authors.lastname: Jensen
authors.forename: A E
authors.initials: AE
authors.lastname: Daigle
authors.forename: S P
authors.initials: SP
authors.lastname: Richieri
authors.forename: A
authors.initials: A
authors.lastname: Truckenbrod
authors.forename: R J
authors.initials: RJ
authors.lastname: Trauger
authors.forename: D J
authors.initials: DJ
authors.lastname: Carlo
authors.forename: J
authors.initials: J
authors.lastname: Salk
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D018791:CD4 Lymphocyte Count / Q000187:drug effects; D016049:Didanosine / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology*; D006968:Hypersensitivity, Delayed / Q000276:immunology / Q000821:virology*; D016233:Immunotherapy, Active; D019562:Viral Load; D015215:Zidovudine / Q000493:pharmacokinetics / Q000627:therapeutic use*
chemical_list: D016915:AIDS Vaccines; D015699:HIV Envelope Protein gp120; C098825:HIV-1 immunogen, incomplete Freund's adjuvant; D015215:Zidovudine; D016049:Didanosine