title: Inactivated HIV-1 Immunogen: impact on markers of disease progression.
abstract: The pursuit of valid markers of disease progression in human immunodeficiency virus type 1 (HIV-1) infection is especially relevant considering the potential treatment alternatives that presently are under evaluation. Because HIV-1 infection results in a virally induced immune suppression characterized by the loss of cell-mediated immunity (CMI), depletion of CD4+ cells, loss of core antibody, and an increase in viral burden, these markers seemed to be appropriate to monitor in a controlled study. We monitored a number of virologic, immunologic, and cytologic markers of disease progression in 103 subjects who were enrolled in a 12-month, double-blind, randomized, adjuvant-controlled study of the HIV-1 inactivated Immunogen. The markers included HIV-1 DNA, HIV-1 RNA, CD4 percent, p24 antibody, and lymphocyte proliferation. Analysis of HIV-1 DNA with a quantitatively polymerase chain reaction (PCR) assay indicated a treatment effect on viral burden in the HIV-1 Immunogen-treated group. Analysis of HIV-1 RNA revealed a similar trend favoring the Immunogen-treated group. In addition, a significant effect was shown on CD4 percent and CMI in the Immunogen-treated group. An analysis of CMI that used stimulation indices underrepresented the immunogenicity of the Immunogen. Further examination revealed that the lymphocytes of the HIV-1 Immunogen-treated patients were proliferating in vitro without exogenous antigen. Although the clinical significance of this phenomenon currently is unknown, it may be a relevant prognostic marker for assessment of HIV-1 therapy. The data presented here support the concept that immunotherapy with the HIV-1 Immunogen may slow disease progression.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Immunization Products Limited, a joint venture of Rhône-Poulenc Rorer Incorporated, Collegeville, Pennsylvania.
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
authors.forename: F
authors.initials: F
authors.lastname: Ferré
authors.forename: R
authors.initials: R
authors.lastname: Trauger
authors.forename: F
authors.initials: F
authors.lastname: Jensen
authors.forename: A
authors.initials: A
authors.lastname: Daigle
authors.forename: S P
authors.initials: SP
authors.lastname: Richieri
authors.forename: D J
authors.initials: DJ
authors.lastname: Carlo
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D015415:Biomarkers; D015496:CD4-Positive T-Lymphocytes; D004279:DNA, Viral / Q000097:blood; D006679:HIV Seropositivity / Q000276:immunology / Q000628:therapy*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D016233:Immunotherapy, Active; D007958:Leukocyte Count; D008213:Lymphocyte Activation; D012367:RNA, Viral / Q000097:blood; D015164:Vaccines, Inactivated / Q000627:therapeutic use
chemical_list: D016915:AIDS Vaccines; D015415:Biomarkers; D004279:DNA, Viral; D012367:RNA, Viral; D015164:Vaccines, Inactivated