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       and were withdrawn from the study.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

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