Document 2832
 DOCN  M94A2832
 TI    Therapeutic immunization with HIV gp160 in HIV-seropositive patients.
 DT    9412
 AU    Sandstrom E; Bratt G; Eriksson L; Samuelsson M; Persson C; Volvovitz F;
       Redfield R; Wigzell H; Wahren B; South Hospital, Karolinska Institute,
       Stockholm, Sweden.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):214 (abstract no. PB0287). Unique
       Identifier : AIDSLINE ICA10/94369743
 AB    OBJECTIVE: To evaluate the clinical effect of gp160 immunization in
       HIV-1 infected individuals. The sample size has been calculated to
       detect a 50% reduction in progression. METHODS: Since February 1993, 756
       patients have been enrolled (February 1994) in a two-year trial of
       postinfection immunization with HIV-1 rgp160 LAI. We plan to enrol a
       total of 1000 patients in the Scandinavian countries. Of these 500
       should initially have CD4 counts above 400 and 500 patients between 200
       and 400 CD4 cells. The immunization schedule calls for six 160
       micrograms of gp160 immunizations over the first half year followed by
       boosts every 3 months. The study will be analyzed on an intention to
       treat basis with AIDS defined opportunistic infections or defined CD4
       decreases. Supporting clinical data are, Walter Reed stage, days on sick
       leave or hospitalized, oral thrush, weight, specific and non-specific
       DTH. RESULTS: Recruitment has been good. Of the included 756 patients 53
       have left the study, 9 due to clinical endpoints, 24 due to CD4
       decreases and the rest for other reasons. CONCLUSIONS: This is an
       attempt to define the role of therapeutic immunization in preventing
       progression of HIV infection to AIDS.
 DE    Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL  AIDS
       Vaccines/*THERAPEUTIC USE  Gene Products, env/*IMMUNOLOGY  Human  HIV
       Antigens/*IMMUNOLOGY  HIV Infections/*THERAPY  HIV-1/*IMMUNOLOGY
       Immunization Schedule  *Immunotherapy, Active  Leukocyte Count  Protein
       Precursors/*IMMUNOLOGY  Recombinant Proteins/IMMUNOLOGY  T4 Lymphocytes
       CLINICAL TRIAL  MEETING ABSTRACT

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