AustralieFrV1, Main, Exploration, bibRecord, 00C526

Efficacy and safety of combination therapy with delavirdine and zidovudine: a European/Australian phase II trial

Identifieur interne : 00C526 ( Main/Exploration ); précédent : 00C525; suivant : 00C527

Efficacy and safety of combination therapy with delavirdine and zidovudine: a European/Australian phase II trial

Auteurs : Anne M. M. Been-Tiktak [Pays-Bas] ; Charles A. B. Boucher [Pays-Bas] ; Françoise Brun-Vezinet [France] ; Véronique Joly [France] ; Jan W. Mulder [Pays-Bas] ; J. Jost [Suisse] ; David A. Cooper [Australie] ; Mauro Moroni [Italie] ; José M. Gatell [Espagne] ; Schlomo Staszewski [Allemagne] ; Robert Colebunders [Belgique] ; Graeme J. Stewart [Australie] ; David A. Hawkins [Royaume-Uni] ; Margaret A. Johnson [Royaume-Uni] ; Jacqueline M. Parkin [Royaume-Uni] ; Dermot H. Kennedy [Royaume-Uni] ; Jennifer F. Hoy [Australie] ; Jan C. C. Borleffs [Pays-Bas]

Source :

International Journal of Antimicrobial Agents [ 0924-8579 ] ; 1999.

RBID : ISTEX:222583409E60A1F786D16E3885AE2D79E27D7FAE

Descripteurs français

Pascal (Inist)
- Antiviral, Association médicamenteuse, Chimiothérapie, Didésoxynucléoside, Délavirdine, Efficacité traitement, Homme, Inhibiteur enzyme, Pyrimidine nucléoside, RNA-directed DNA polymerase, SIDA, Toxicité, Traitement, Zidovudine.
Wicri :
- topic : Homme.

English descriptors

Abstract

Abstract: The objective of the study was to investigate the safety and antiviral effect of three delavirdine dose regimens or placebo in combination with zidovudine in patients who were already taking zidovudine. Eighty-nine symptomatic HIV-1 seropositive individuals with CD4+ cell counts between 50 and 350 cells/μl were included in this trial The influence of combination therapy on viral susceptibility to both zidovudine and delavirdine was investigated. Death or the occurrence, or re-occurrence of an AIDS-defining illness was considered as a clinical endpoint. The addition of delavirdine to the antiretroviral treatment regimen resulted in a significant, but transient, reduction in virus load, as determined by quantitative RNA measurements. CD4+ cell count did not change significantly. Susceptibility to zidovudine remained unchanged after 12 weeks of combination therapy, while 70% of the patients demonstrated a substantial decrease (>10-fold) in sensitivity to delavirdine. Two patients suffered from an AIDS-defining disease during the study. No deaths occurred. Generally, the drug appeared to be safe. Skin rash was the most frequently observed adverse event (52%). In most patients the rash either resolved spontaneously or was treated successfully with a short course of antihistamines. The definite place of the compound in the management of HIV disease, in particular when given in combination with other antiretroviral agents, remains to be further explored.

Url:

https://api.istex.fr/document/222583409E60A1F786D16E3885AE2D79E27D7FAE/fulltext/pdf

DOI: 10.1016/S0924-8579(98)00082-X

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en">Abstract: The objective of the study was to investigate the safety and antiviral effect of three delavirdine dose regimens or placebo in combination with zidovudine in patients who were already taking zidovudine. Eighty-nine symptomatic HIV-1 seropositive individuals with CD4+ cell counts between 50 and 350 cells/μl were included in this trial The influence of combination therapy on viral susceptibility to both zidovudine and delavirdine was investigated. Death or the occurrence, or re-occurrence of an AIDS-defining illness was considered as a clinical endpoint. The addition of delavirdine to the antiretroviral treatment regimen resulted in a significant, but transient, reduction in virus load, as determined by quantitative RNA measurements. CD4+ cell count did not change significantly. Susceptibility to zidovudine remained unchanged after 12 weeks of combination therapy, while 70% of the patients demonstrated a substantial decrease (>10-fold) in sensitivity to delavirdine. Two patients suffered from an AIDS-defining disease during the study. No deaths occurred. Generally, the drug appeared to be safe. Skin rash was the most frequently observed adverse event (52%). In most patients the rash either resolved spontaneously or was treated successfully with a short course of antihistamines. The definite place of the compound in the management of HIV disease, in particular when given in combination with other antiretroviral agents, remains to be further explored.</div>
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Serveur d'exploration sur les relations entre la France et l'Australie

Efficacy and safety of combination therapy with delavirdine and zidovudine: a European/Australian phase II trial

Efficacy and safety of combination therapy with delavirdine and zidovudine: a European/Australian phase II trial

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	Serveur d'exploration sur les relations entre la France et l'Australie
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