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M94A2882.TXT
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1994-10-25
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Document 2882
DOCN M94A2882
TI Loviride induces a prolonged rise of the CD4 count in asymptomatic
HIV-1+ subjects.
DT 9412
AU De Brabander M; Staszewski S; De Cree J; Verhaegen H; Stoffels P; Van
Den Broeck R; Roels V; Janssen PA; CRU St. Bartholomeus, Merksem,
Belgium.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):203 (abstract no. PB0242). Unique
Identifier : AIDSLINE ICA10/94369693
AB OBJECTIVE: to compare the effect on CD4 count of treatment with placebo
or with the alpha-APA compounds R18893 and loviride (R89439) a new
derivative with improved activity and selectivity and greatly enhanced
bioavailability (plasma levels > 100x the IC50 for HIV-1) METHODS:
double blind, double dummy investigation of 24 weeks on 114 evaluable
participants with baseline CD4 count > 400 or > 20%. Monthly clinical
and laboratory evaluation. Main parameter CD4 count and percentage
determined on 3 separate samples to improve accuracy. RESULTS: with
placebo or R18893 treatment the mean CD4 number fluctuated around
baseline and the mean CD4% decreased progressively to +/- 95% of
baseline. Loviride induced a significant increase of the CD4% to +/-
105% of baseline (p = .035 versus placebo, general linear model with
mixed effects) The number of CD4 lymphocytes fluctuated between 110-120%
of baseline up to the end of the study (24 weeks; p = 0.005 versus
placebo). In the placebo group the number of patients with increased or
stable CD4 counts fluctuated around 50% while this was 60-70% in the
loviride group. Both loviride and R18893 were very well tolerated
(Staszewski et al. this meeting). Sofar, the resistance conferring
mutations Y-181 or Y106 did not appear in plasma samples (last analysis
= 3 months, further data available at meeting by Staszewski et al.)
DISCUSSION AND CONCLUSIONS: loviride treatment produced a long lasting
rise in the CD4 count in asymptomatic patients in the absence of any
side effects and without inducing the early appearance of resistant
virus strains. It appears to be the alpha-APA compound of choice for
further investigations in mono- and in combination-therapy.
DE Acetamides/*PHARMACOLOGY Acetophenones/*PHARMACOLOGY Antiviral
Agents/*PHARMACOLOGY Comparative Study Double-Blind Method Human HIV
Infections/BLOOD/*DRUG THERAPY Leukocyte Count/*DRUG EFFECTS Reverse
Transcriptase/*ANTAGONISTS & INHIB Treatment Outcome *T4 Lymphocytes
CLINICAL TRIAL MEETING ABSTRACT RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).