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M94A2857.TXT
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1994-10-25
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Document 2857
DOCN M94A2857
TI Retrospective study of zidovudine (ZDV) or didanosine (ddI) monotherapy
or zalcitabine plus zidovudine (ddC + ZDV) combination therapy in
patients with early AIDS.
DT 9412
AU Barr M; Torres RA; St. Vincent's Hospital and Medical Center, NYC.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):209 (abstract no. PB0266). Unique
Identifier : AIDSLINE ICA10/94369718
AB OBJECTIVE: To assess the relative efficacies of zidovudine (ZDV) and
didanosine (ddI) monotherapies compared to combination therapy with
zalcitabine (ddC) plus zidovudine (ZDV) in 150 patients with early AIDS.
METHODS: One hundred and fifty ZDV-experienced persons attending the St.
Vincent's Hospital out-patient HIV clinic who either (1) remained on
zidovudine (ZDV) monotherapy or who (2) switched to didanosine (ddI)
monotherapy or (3) to combination therapy with zalcitabine plus
zidovudine (ddC + ZDV) were followed. The primary endpoints in this
study were development of new opportunistic infections and death.
Differences in rates of adverse events were also compared. RESULTS:
Patients in the 3 groups were similar in terms of baseline demographics.
Mean baseline CD4 count was 124 cells/mm3; mean duration of prior
zidovudine, 15.5 months. Mean follow-up time was 30 weeks. Both
time-adjusted mean number of hospitalizations (ZDV, 22.1; ddI, 17.0; ddC
+ ZDV, 19.3) and rate of new opportunistic infections (ZDV, 13.8%; ddI,
9.7%; ddC + ZDV, 24.1%) were lowest in the didanosine (ddI) group. Rate
of adverse events requiring discontinuation of therapy were higher in
the combination group (25.1%) than in the ddI (17.7%) or ZDV (15.8%)
groups. CONCLUSION: In ZDV-experienced patients with early AIDS,
switching to didanosine (ddI) may confer a clinical benefit as measured
by a reduced number of hospitalizations and of new opportunistic
infections. Combination therapy with zalcitabine plus zidovudine (ddC +
ZDV), however, appears inferior to both ZDV and ddI monotherapies, and
results in considerably more adverse reactions.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MORTALITY AIDS-Related
Opportunistic Infections/PREVENTION & CONTROL Comparative Study
Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE Drug Therapy, Combination
Human Retrospective Studies Treatment Outcome
Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
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).