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M94A2840.TXT
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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).