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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
protected by Copyright Law (Title 17, U.S.Code).