Document 2840
 DOCN  M94A2840
 TI    Zalcitabine (ddC) in combination with zidovudine (ZDV,AZT) for treatment
       of advanced HIV disease. A multicenter, open label, non comparative
       study.
 DT    9412
 AU    Perez-Ancona F; Cano C; Lisker A; Montenegro A; Depto. 65-1 Col.
       Pedregal de Carrasco, Coyoacan Mexico D.F.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):212 (abstract no. PB0278). Unique
       Identifier : AIDSLINE ICA10/94369735
 AB    OBJECTIVE: To evaluate the safety, tolerance and efficacy of zalcitabine
       (2.25 mg/d) plus ZDV (600 mg/d) in patients with advanced HIV-infection
       with CD4 counts of less than 300 cells/mm3. METHODS: Preliminary
       analysis includes 84 patients with AIDS or advanced HIV-infection (less
       than 300 CD4/mm3) who had received the combination regimen for six
       months. The safety of the therapy was evaluated with variance analysis
       by comparing the incidence of clinical adverse events, marked laboratory
       abnormalities, hematologic toxicities at entry vs those at 8, 12 weeks
       and 6 months of follow up. RESULTS: median age of the 84 patients
       included was 35.02 years, 7 were excluded for this analysis, 3 for
       neoplasias developed during the study (2 Kaposi sarcomas and 1
       Non-Hodgkin linfoma), 1 patient died during week 10 due to causes not
       related to treatment (severe respiratory failure due to Pneumocystis
       pneumonia) and three were lost to follow up. 66 men and 11 women remain
       in the study and were considered for analysis, 64 (83%) acquired the
       infection through sexual contact and 13 through transfusion of blood or
       blood products. All 77 patients had received ZDV for an average of 17.8
       months and the median CD4 count at entry was 160.8 cells/mm3. The most
       common adverse events were leukopenia in 26 occasions, anemia in 22,
       oral ulcers and rises in liver transaminases in 15 cases each. Other
       adverse events were nausea in 9 cases and transient erythema in 4. Only
       3 patients developed peripheral neuropathy considered to be probable or
       possibly related to zalcitabine which was reversible after stopping the
       drug. Hyperamylasemia also occurred in three. Most adverse events
       occurred during the first 8 weeks of drug administration (48) and were
       reversible in all cases after temporarily reducing ZDV in 24 cases and
       zalcitabine in 8. CONCLUSIONS: zalcitabine plus ZDV in advanced
       HIV-infection is well tolerated up to this point with no serious adverse
       events, nevertheless there was a high incidence of myelotoxicity which
       led to reduction of ZDV in 24 patients (31.1%), this might indicate that
       Mexican patients with advanced HIV infection may show less toxicity with
       lower doses, specially when it is administered in combination. CD4 cell
       counts did not show any significant change. We need a longer follow up
       period in order to further evaluate the safety profile of this form of
       combination therapy.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY  Adult  Bone Marrow
       Diseases/CHEMICALLY INDUCED  Digestive System Diseases/CHEMICALLY
       INDUCED  Drug Therapy, Combination  Female  Human  Leukopenia/CHEMICALLY
       INDUCED  Male  Peripheral Nervous System Diseases/CHEMICALLY INDUCED
       Safety  Treatment Outcome  Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  CLINICAL TRIAL  MEETING ABSTRACT  MULTICENTER
       STUDY

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