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).