Document 2802
 DOCN  M94A2802
 TI    Effects of HIV-1 immunogen on clinical status.
 DT    9412
 AU    Bergman G; Moss R; Petillo J; Slade H
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):221 (abstract no. PB0314). Unique
       Identifier : AIDSLINE ICA10/94369773
 AB    METHODS: HIV-1 Immunogen is a gp 120 depleted, whole inactivated virus
       administered in Incomplete Freud's Adjuvant (IFA). In a double-blind,
       randomized, IFA-controlled one year study at nine sites, 103 HIV-1
       infected adults received an injections of HIV-1 Immunogen or IFA control
       at 0, 3, 6 months. Patients had CD4 cell counts > 550/mm3, intact
       humoral immunity and intact cellular immunity; none received
       antiretroviral therapy at study entry. Cellular and humoral immunity,
       viral burden (quantitative HIV-DNA by PCR) and clinical evaluations were
       performed every 8 weeks for one year. RESULTS: No serious adverse
       effects of the HIV-1 Immunogen were reported; local mild injection site
       reactions were common. Treated patients had a significant increase in
       weight from baseline not seen in controls (p = 0.028). No difference in
       disease progression (1993 CDC) was seen between groups. A significant
       increase at 32 weeks was observed for anti-p24 antibodies in treated
       patients compared to controls (p < 0.008). A slower rate of increase in
       viral burden over time occurred in treated patients vs. controls when
       adjusted for CD4 cell percent (p = 0.016). More treated patients had a
       decrease in copy numbers at study end (p = 0.033). Treated patients'
       lymphocytes displayed vigorous autoproliferative activity without
       exogenous antigen in T-cell proliferation assays, and displayed a
       greater stimulation index over time to HIV-1 Immunogen (p < 0.001) and
       native p24 (p < 0.007). CD4 cell counts decreased more rapidly in
       controls than in treated patients over time (p = 0.021). DISCUSSION:
       HIV-1 Immunogen in IFA demonstrated treatment effects in HIV infected
       adults maximally after the third injection. These potentially beneficial
       effects on weight gain, anti-p24 antibody titer, CD4 cell count, and
       viral burden suggest treatment with HIV-1 Immunogen may favorably alter
       the natural history of disease progression in HIV-1 infected patients.
       Prospective studies to assess clinical endpoints are essential to
       evaluate this immunotherapy in HIV-1 infected individuals.
 DE    Adult  Antibody Formation  AIDS Vaccines/*THERAPEUTIC USE  Double-Blind
       Method  DNA, Viral/BLOOD  Human  HIV Core Protein p24/ANALYSIS  HIV
       Infections/IMMUNOLOGY/MICROBIOLOGY/*THERAPY  HIV-1/*IMMUNOLOGY/ISOLATION
       & PURIF  Immunity, Cellular  *Immunotherapy, Active  Lymphocyte
       Transformation  Polymerase Chain Reaction  Treatment Outcome  Vaccines,
       Inactivated/THERAPEUTIC USE  Viremia/THERAPY  Weight Gain  CLINICAL
       TRIAL  MEETING ABSTRACT  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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