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M94A2866.TXT
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1994-10-25
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Document 2866
DOCN M94A2866
TI Effects of combined treatment with zidovudine and dideoxyinosine in 104
HIV+ patients with prior zidovudine therapy.
DT 9412
AU de Saint Martin L; Pialoux G; Tuppin P; Gonzalez-Canali G; Feuillie V;
Dupont B; Institut Pasteur Hospital, Paris, France.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):207 (abstract no. PB0258). Unique
Identifier : AIDSLINE ICA10/94369709
AB OBJECTIVES: 104 HIV infected patients with infection progressing in
spite of ongoing AZT were enrolled into a longitudinal retrospective
study of safety and impact on disease course of combined therapy with
zidovudine (AZT) and dideoxyinosine (ddI). METHODS: All patients of our
AIDS clinical unit who had been treated with zidovudine alone and who
received subsequently a combination therapy between November 17, 1990
and December 1, 1992 were included in this study. The analysis of
clinical manifestations was based on any significant clinical event.
Biological evaluation included CD4+/CD8+ count and HIV p24 antigen
level. The number of clinical events and the number of serious
biological events, before and after onset of combined therapy was
compared using Chi square or Fischer exact tests. Comparisons between
pretreatment characteristics of responders and no responders were made
using a Fischer exact test or a Kruskal Wallis test. RESULTS: the mean
of follow up was 190 days (range 32-849). All patients were treated with
daily doses of AZT between 200 and 600 mg (mean = 396) and daily doses
of ddI between 100 and 600 mg (mean = 359). Study medication was
discontinued in 34 patients, related in 17 cas to adverse reactions. The
increase of mean slope of CD4+ lymphocytes count was significant but not
the decrease of the mean slope of HIV p24 antigen level. Statistical
limits of this longitudinal retrospective study do not permit to
conclude but the efficacy at this stage of the decrease is probably
slight. DISCUSSION AND CONCLUSION: Combined therapy with AZT and ddI
following AZT therapy alone among patients with HIV disease progression
showed disappointing results. The increase of the toxicity is smaller.
The improvement of laboratory parameters of HIV infection is small
(CD4+) or nonexistent (Ag p24). Further investigations must be performed
to establish a long-term efficacy of antiretroviral combination.
DE Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
Drug Therapy, Combination Human HIV Core Protein p24/BLOOD HIV
Infections/*DRUG THERAPY Leukocyte Count Longitudinal Studies
Retrospective Studies Safety Treatment Outcome T4 Lymphocytes
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).