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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).