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M94A2825.TXT
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1994-10-25
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Document 2825
DOCN M94A2825
TI IL-2 administration to HIV+ individuals and AIDS patients. An open-label
study performed in Sao Paulo, Brazil.
DT 9412
AU Timerman A; Hutzler RU; Albert Einstein Hospital, Sao Paulo, Brazil.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):216 (abstract no. PB0292). Unique
Identifier : AIDSLINE ICA10/94369750
AB IL-2 is considered an immunomodulatory lymphokine that could play a role
in stabilizing the progression of HIV infection in the long-term
survivors group of patients, and therefore, would have a role if
administered to individuals who are characterized as presenting
progressive or potentially progressive forms of HIV infection. IL-2 is a
potentially dangerous substance, that has been used as a therapeutic
option in patients with metastatic renal carcinoma and melanoma. As part
of our office practice we have been following more than 700 HIV+
patients. As of 02/01/1993 we have been administering IL-2, after
informed consent, to 32 patients in different stages of the HIV disease
spectrum. 18 pts were HIV+ asymptomatic individuals with CD4 cell counts
> 200 cells/mm3 < 500 cells/mm3. 7 pts. were HIV+ asymptomatic
individuals with CD4 cell counts < 200 cells/mm3 > 100 cells/mm3. 2 pts
were HIV+ asymptomatic individuals with CD4 cell counts < 100 cells/mm3.
5 pts were AIDS patients, with CD4 cell counts < 100 cells/mm3. The drug
was administered as a continuous infusion at the initial dose of
18.10(6) Cetus Units/24 h. The initial aim was to administer 5 infusions
in 5 consecutive days, with an interval of 8 weeks between each cycle,
performing a total of 3 initial cycles. We report the findings after the
administration of 2 cycles to these 32 patients who were receiving
concomitantly antiretroviral therapy with the association ZDV + ddC or
ddI alone. In terms of safety, 3//32 pts concluded the cycles as
initially programmed. The most frequent adverse reactions were: rash
(31/32), fever (31/32), malaise (30/32), dizziness (27/32), nausea and
vomiting (21/32). Less frequent and limiting the administered dose was
observed: Hypotension (12/32), increased creatinine and urea levels [>
50% baseline value (11/32)], platelet count reduction (6/32). The
efficacy was evaluated in terms of increase in the CD4 cell count and
the time this increase was maintained. The data regarding efficacy will
be presented and correlated with clinical parameters and the conclusion
will be based on these data.
DE Acquired Immunodeficiency Syndrome/DRUG THERAPY/THERAPY Biological
Response Modifiers/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC
USE Combined Modality Therapy Didanosine/ADMINISTRATION &
DOSAGE/THERAPEUTIC USE Dizziness/CHEMICALLY INDUCED Drug
Eruptions/ETIOLOGY Drug Therapy, Combination Fever/CHEMICALLY INDUCED
Gastrointestinal Diseases/CHEMICALLY INDUCED Human
Hypotension/CHEMICALLY INDUCED HIV Infections/DRUG THERAPY/*THERAPY
Interleukin-2/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE
Leukocyte Count Safety Thrombocytopenia/CHEMICALLY INDUCED Treatment
Outcome T4 Lymphocytes Zalcitabine/ADMINISTRATION & DOSAGE/THERAPEUTIC
USE Zidovudine/ADMINISTRATION & DOSAGE/THERAPEUTIC USE CLINICAL TRIAL
MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).