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M94A2865.TXT
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1994-10-25
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Document 2865
DOCN M94A2865
TI Open label combination of zidovudine (ZVD) plus didanosine (DDI) for the
treatment of patients with HIV infection and absolute CD4 lymphocytes
counts > 100 < 500 mega/l.
DT 9412
AU Suleiman G; Suleiman J; Suleiman S; Castro I; Ferreira Junior O;
Instituto de Infectologia Emilio Ribas, Sao Paulo, Brazil.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):207 (abstract no. PB0257). Unique
Identifier : AIDSLINE ICA10/94369710
AB In this ongoing study, 34 patients with HIV infection and CD4 counts >
100 < 500 mega/l were admited from February 1993 through April 1993. Its
objective is to evaluate the safety of ddI 200 mg administered on a
b.i.d. regimen (every 12 hours) plus ZDV 100 mg administered t.i.d.
(every 8 hours) for a one year period. There were 16 males and 18
females in the study with age ranging from 21 to 52 (average 36.5 years
old). Four patients refused to receive treatment for personal reasons
and were withdrawn from the study. For all 34 patients, median baseline
CD4 counts at study entry was 363 +/- 82 (range 179 to 500). On the
nineth month of treatment for 24 patients analysed CD4 median count was
513 +/- 162 (range 159 to 898), p < 0.0001. Until the present date none
of the 30 patients involved in the study has presented any opportunistic
infection. In the evaluation of hematologic an biochemistry parameters
it has been observed that hemoglobin, red blood cell, neutrophils an
platelets counts, as well as potassium, glucose, BUN, serum creatinine,
ureia acid have maintained baseline levels. Hyperamilasemia was observed
in 7 of the 30 patients, with no clinical signs. Severe hipocalcemia was
observed in 1 (30 patients). Preliminary analysis of this study
demonstrates that the combination of ddI and ZDV at the above mentioned
is safe to be administered to HIV+ patients with CD4 counts > 100 < 500
mega/l, and it seems to delay opportunistic infections in this patients
group.
DE Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
Drug Administration Schedule Drug Therapy, Combination Human HIV
Infections/*DRUG THERAPY Leukocyte Count Safety Treatment Outcome T4
Lymphocytes Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE
EFFECTS/*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).