Document 2896
 DOCN  M94A2896
 TI    Randomized comparative trial of ZDV+ddI vs ZDV+ddC on short-term safety
       and laboratory markers in subjects with CD4s of 50 to 350/microL.
       Canadian HIV Trials Network.
 DT    9412
 AU    Montaner JS; Srour L; Singer J; Cassol S; O'Shaughnessy MV; Schechter
       MT; Bristol-Myers & Squibb, Canada.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):20 (abstract no. 055B). Unique
       Identifier : AIDSLINE ICA10/94369679
 AB    OBJECTIVE: To compare the short term safety and surrogate marker effects
       of ZDV/ddI vs. ZDV/ddC. METHODS: HIV+ patients tolerant of ZDV > or =
       400 mg/d were eligible if they were ddI and ddC naive and had CD4 counts
       of 50 to 350/mm3. Eligible patients could select between the open arm of
       the study, namely choosing between ZDV+ddI and ZDV+ddC, or randomization
       to either regimen in full doses on an open label basis. Drugs were made
       available free of charge for both arms of the study. Patients were
       stratified according to whether they had previously treated with ZDV and
       to CD4 count at baseline (< or = 100 and > or = 100/mm3). Randomized
       patients were seen at 1, 2, 3, 5 and 7 months for assessment of clinical
       status, adverse effects, CD4 count, P24 antigen and quantitative plasma
       HIV-RNA PCR. RESULTS: A total of 136 patients have been randomized:
       67-ZDV+ddI; 69-ZDV+ddC. 92% were male, 75% gay or bisexual; mean age =
       38. Only 1.5% of patients had AIDS at entry. Mean baseline CD4 count was
       230. Change in CD4 count over time for patients remaining on assigned
       study therapy, to date, is shown in the figure. Both groups experienced
       a significant rise in CD4 count. Although there was a trend in favour of
       ZDV/ddI, this has not reached statistical significance. Adverse events
       resulted in reduction or discontinuation in 26% and 20% of ddI and ddC
       treated patients, respectively. This was most commonly due to peripheral
       neuropathy (ddI = 6; ddC = 5). P24 antigen and quantitative plasma
       HIV-RNA PCR results are pending. CONCLUSIONS: Our preliminary analysis
       demonstrates that short term use of ZDV+ddI or ZDV+ddC is associated
       with a significant increase in CD4 count. Although a trend was found in
       favor of ZDV/ddI, this did not reach statistical significance. Short
       term safety profile was similar between both regimens. P24 antigen and
       quantitative plasma HIV-RNA PCR results are pending. TABULAR DATA, SEE
       ABSTRACT VOLUME.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY  Adult  Comparative
       Study  Didanosine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Drug
       Therapy, Combination  Female  Human  HIV Seropositivity/*DRUG THERAPY
       Male  Support, Non-U.S. Gov't  T4 Lymphocytes
       Zalcitabine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
       Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  CLINICAL TRIAL
       MEETING ABSTRACT  RANDOMIZED CONTROLLED TRIAL

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