Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial
Identifieur interne : 00D777 ( Main/Merge ); précédent : 00D776; suivant : 00D778Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial
Auteurs : A. M. M. Been-Tiktak [Pays-Bas] ; C. A. B. Boucher [Pays-Bas] ; F. Brun-Vezinet [France] ; V. Joly [France] ; J. W. Mulder [Pays-Bas] ; J. Jost [Suisse] ; D. A. Cooper [Australie] ; M. Moroni [Italie] ; J. M. Gatell [Espagne] ; S. Staszewski [Allemagne] ; R. Colebunders [Belgique] ; G. J. Stewart [Australie] ; D. A. Hawkins [Royaume-Uni] ; M. A. Johnson [Royaume-Uni] ; J. M. Parkin [Royaume-Uni] ; D. H. Kennedy [Royaume-Uni] ; J. F. Hoy [Australie] ; J. C. C. Borleffs [Pays-Bas]Source :
- International journal of antimicrobial agents [ 0924-8579 ] ; 1999.
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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-I 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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial</title><author><name sortKey="Been Tiktak, A M M" sort="Been Tiktak, A M M" uniqKey="Been Tiktak A" first="A. M. M." last="Been-Tiktak">A. M. M. Been-Tiktak</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Internal Medicine, Subdivision of Infectious Diseases and AIDS, University Hospital Utrect, P.O. Box 85500</s1><s2>3508 GA Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>3508 GA Utrecht</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Eijkman-Winkler Institute of Medical Microbiology, University Hospital</s1><s2>Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Boucher, C A B" sort="Boucher, C A B" uniqKey="Boucher C" first="C. A. B." last="Boucher">C. A. B. 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Joly</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Internal Medicine, Bichat-Claude Bernard Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mulder, J W" sort="Mulder, J W" uniqKey="Mulder J" first="J. W." last="Mulder">J. W. Mulder</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Internal Medicine, Slotervaart Hospital</s1><s2>Amsterdam</s2><s3>NLD</s3><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Jost, J" sort="Jost, J" uniqKey="Jost J" first="J." last="Jost">J. Jost</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Infectious Diseases, University Hospital</s1><s2>Zürich</s2><s3>CHE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suisse</country><placeName><settlement type="city">Zurich</settlement><region nuts="3" type="region">Canton de Zurich</region></placeName></affiliation></author><author><name sortKey="Cooper, D A" sort="Cooper, D A" uniqKey="Cooper D" first="D. A." last="Cooper">D. A. Cooper</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>HIV Medicine Unit, St Vincent's Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Moroni, M" sort="Moroni, M" uniqKey="Moroni M" first="M." last="Moroni">M. Moroni</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Clinic of Infectious Diseases, Sant'Orsola Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Gatell, J M" sort="Gatell, J M" uniqKey="Gatell J" first="J. M." last="Gatell">J. M. Gatell</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Servicio de Infecciones, Hospital Clinic i Provincial</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>9 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Staszewski, S" sort="Staszewski, S" uniqKey="Staszewski S" first="S." last="Staszewski">S. Staszewski</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Infectious Diseases, Goethe University Hospital</s1><s2>Frankfurt</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Colebunders, R" sort="Colebunders, R" uniqKey="Colebunders R" first="R." last="Colebunders">R. Colebunders</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Institute of Tropical Medicine</s1><s2>Antwerp</s2><s3>BEL</s3><sZ>11 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Institute of Tropical Medicine</wicri:noRegion></affiliation></author><author><name sortKey="Stewart, G J" sort="Stewart, G J" uniqKey="Stewart G" first="G. J." last="Stewart">G. J. Stewart</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Department of Clinical Immunology, Westmead Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hawkins, D A" sort="Hawkins, D A" uniqKey="Hawkins D" first="D. A." last="Hawkins">D. A. Hawkins</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>St. Stephen Centre, Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Johnson, M A" sort="Johnson, M A" uniqKey="Johnson M" first="M. A." last="Johnson">M. A. Johnson</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Department of Thoracic Surgery, Royal Free Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>14 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Parkin, J M" sort="Parkin, J M" uniqKey="Parkin J" first="J. M." last="Parkin">J. M. Parkin</name><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Department of Immunology, St. Bartholomews Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kennedy, D H" sort="Kennedy, D H" uniqKey="Kennedy D" first="D. H." last="Kennedy">D. H. Kennedy</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Infection and Tropical Medicine, Ruchill Hospital</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>16 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow</wicri:noRegion></affiliation></author><author><name sortKey="Hoy, J F" sort="Hoy, J F" uniqKey="Hoy J" first="J. F." last="Hoy">J. F. Hoy</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Department of Microbiology and Infectious Diseases, Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Borleffs, J C C" sort="Borleffs, J C C" uniqKey="Borleffs J" first="J. C. C." last="Borleffs">J. C. C. Borleffs</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Internal Medicine, Subdivision of Infectious Diseases and AIDS, University Hospital Utrect, P.O. Box 85500</s1><s2>3508 GA Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>3508 GA Utrecht</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">99-0157901</idno><date when="1999">1999</date><idno type="stanalyst">PASCAL 99-0157901 INIST</idno><idno type="RBID">Pascal:99-0157901</idno><idno type="wicri:Area/PascalFrancis/Corpus">006421</idno><idno type="wicri:Area/PascalFrancis/Curation">006C33</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">006064</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">006064</idno><idno type="wicri:doubleKey">0924-8579:1999:Been Tiktak A:efficacy:and:safety</idno><idno type="wicri:Area/Main/Merge">00D777</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial</title><author><name sortKey="Been Tiktak, A M M" sort="Been Tiktak, A M M" uniqKey="Been Tiktak A" first="A. M. M." last="Been-Tiktak">A. M. M. Been-Tiktak</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Internal Medicine, Subdivision of Infectious Diseases and AIDS, University Hospital Utrect, P.O. Box 85500</s1><s2>3508 GA Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>3508 GA Utrecht</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Eijkman-Winkler Institute of Medical Microbiology, University Hospital</s1><s2>Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Boucher, C A B" sort="Boucher, C A B" uniqKey="Boucher C" first="C. A. B." last="Boucher">C. A. B. Boucher</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Eijkman-Winkler Institute of Medical Microbiology, University Hospital</s1><s2>Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Brun Vezinet, F" sort="Brun Vezinet, F" uniqKey="Brun Vezinet F" first="F." last="Brun-Vezinet">F. Brun-Vezinet</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Virology, Bichat-Claude Bernard Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Joly, V" sort="Joly, V" uniqKey="Joly V" first="V." last="Joly">V. Joly</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Internal Medicine, Bichat-Claude Bernard Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mulder, J W" sort="Mulder, J W" uniqKey="Mulder J" first="J. W." last="Mulder">J. W. Mulder</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Internal Medicine, Slotervaart Hospital</s1><s2>Amsterdam</s2><s3>NLD</s3><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Jost, J" sort="Jost, J" uniqKey="Jost J" first="J." last="Jost">J. Jost</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Infectious Diseases, University Hospital</s1><s2>Zürich</s2><s3>CHE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suisse</country><placeName><settlement type="city">Zurich</settlement><region nuts="3" type="region">Canton de Zurich</region></placeName></affiliation></author><author><name sortKey="Cooper, D A" sort="Cooper, D A" uniqKey="Cooper D" first="D. A." last="Cooper">D. A. Cooper</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>HIV Medicine Unit, St Vincent's Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Moroni, M" sort="Moroni, M" uniqKey="Moroni M" first="M." last="Moroni">M. Moroni</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Clinic of Infectious Diseases, Sant'Orsola Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Gatell, J M" sort="Gatell, J M" uniqKey="Gatell J" first="J. M." last="Gatell">J. M. Gatell</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Servicio de Infecciones, Hospital Clinic i Provincial</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>9 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Staszewski, S" sort="Staszewski, S" uniqKey="Staszewski S" first="S." last="Staszewski">S. Staszewski</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Infectious Diseases, Goethe University Hospital</s1><s2>Frankfurt</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Colebunders, R" sort="Colebunders, R" uniqKey="Colebunders R" first="R." last="Colebunders">R. Colebunders</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Institute of Tropical Medicine</s1><s2>Antwerp</s2><s3>BEL</s3><sZ>11 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Institute of Tropical Medicine</wicri:noRegion></affiliation></author><author><name sortKey="Stewart, G J" sort="Stewart, G J" uniqKey="Stewart G" first="G. J." last="Stewart">G. J. Stewart</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Department of Clinical Immunology, Westmead Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hawkins, D A" sort="Hawkins, D A" uniqKey="Hawkins D" first="D. A." last="Hawkins">D. A. Hawkins</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>St. Stephen Centre, Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Johnson, M A" sort="Johnson, M A" uniqKey="Johnson M" first="M. A." last="Johnson">M. A. Johnson</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Department of Thoracic Surgery, Royal Free Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>14 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Parkin, J M" sort="Parkin, J M" uniqKey="Parkin J" first="J. M." last="Parkin">J. M. Parkin</name><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Department of Immunology, St. Bartholomews Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kennedy, D H" sort="Kennedy, D H" uniqKey="Kennedy D" first="D. H." last="Kennedy">D. H. Kennedy</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Infection and Tropical Medicine, Ruchill Hospital</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>16 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow</wicri:noRegion></affiliation></author><author><name sortKey="Hoy, J F" sort="Hoy, J F" uniqKey="Hoy J" first="J. F." last="Hoy">J. F. Hoy</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Department of Microbiology and Infectious Diseases, Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>17 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Borleffs, J C C" sort="Borleffs, J C C" uniqKey="Borleffs J" first="J. C. C." last="Borleffs">J. C. C. Borleffs</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Internal Medicine, Subdivision of Infectious Diseases and AIDS, University Hospital Utrect, P.O. Box 85500</s1><s2>3508 GA Utrecht</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>3508 GA Utrecht</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">International journal of antimicrobial agents</title><title level="j" type="abbreviated">Int. j. antimicrob. agents</title><idno type="ISSN">0924-8579</idno><imprint><date when="1999">1999</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">International journal of antimicrobial agents</title><title level="j" type="abbreviated">Int. j. antimicrob. agents</title><idno type="ISSN">0924-8579</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term><term>Antiviral</term><term>Chemotherapy</term><term>Delavirdine</term><term>Dideoxynucleoside</term><term>Drug combination</term><term>Enzyme inhibitor</term><term>Human</term><term>Pyrimidine nucleoside</term><term>RNA-directed DNA polymerase</term><term>Toxicity</term><term>Treatment</term><term>Treatment efficiency</term><term>Zidovudine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Délavirdine</term><term>Zidovudine</term><term>Antiviral</term><term>Inhibiteur enzyme</term><term>RNA-directed DNA polymerase</term><term>SIDA</term><term>Association médicamenteuse</term><term>Traitement</term><term>Chimiothérapie</term><term>Efficacité traitement</term><term>Toxicité</term><term>Homme</term><term>Pyrimidine nucléoside</term><term>Didésoxynucléoside</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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-I seropositive individuals with CD4<sup>+</sup> 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<sup>+</sup> 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></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Italie</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Canton de Zurich</li><li>Catalogne</li><li>District de Darmstadt</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Hollande-Septentrionale</li><li>Nouvelle-Galles du Sud</li><li>Utrecht (province)</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Amsterdam</li><li>Barcelone</li><li>Francfort-sur-le-Main</li><li>Londres</li><li>Melbourne</li><li>Paris</li><li>Sydney</li><li>Utrecht</li><li>Zurich</li></settlement></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Been Tiktak, A M M" sort="Been Tiktak, A M M" uniqKey="Been Tiktak A" first="A. M. M." last="Been-Tiktak">A. M. M. Been-Tiktak</name></noRegion><name sortKey="Been Tiktak, A M M" sort="Been Tiktak, A M M" uniqKey="Been Tiktak A" first="A. M. M." last="Been-Tiktak">A. M. M. Been-Tiktak</name><name sortKey="Borleffs, J C C" sort="Borleffs, J C C" uniqKey="Borleffs J" first="J. C. C." last="Borleffs">J. C. C. Borleffs</name><name sortKey="Boucher, C A B" sort="Boucher, C A B" uniqKey="Boucher C" first="C. A. B." last="Boucher">C. A. B. Boucher</name><name sortKey="Mulder, J W" sort="Mulder, J W" uniqKey="Mulder J" first="J. W." last="Mulder">J. W. Mulder</name></country><country name="France"><region name="Île-de-France"><name sortKey="Brun Vezinet, F" sort="Brun Vezinet, F" uniqKey="Brun Vezinet F" first="F." last="Brun-Vezinet">F. Brun-Vezinet</name></region><name sortKey="Joly, V" sort="Joly, V" uniqKey="Joly V" first="V." last="Joly">V. Joly</name></country><country name="Suisse"><region name="Canton de Zurich"><name sortKey="Jost, J" sort="Jost, J" uniqKey="Jost J" first="J." last="Jost">J. Jost</name></region></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Cooper, D A" sort="Cooper, D A" uniqKey="Cooper D" first="D. A." last="Cooper">D. A. Cooper</name></region><name sortKey="Hoy, J F" sort="Hoy, J F" uniqKey="Hoy J" first="J. F." last="Hoy">J. F. Hoy</name><name sortKey="Hoy, J F" sort="Hoy, J F" uniqKey="Hoy J" first="J. F." last="Hoy">J. F. Hoy</name><name sortKey="Stewart, G J" sort="Stewart, G J" uniqKey="Stewart G" first="G. J." last="Stewart">G. J. Stewart</name><name sortKey="Stewart, G J" sort="Stewart, G J" uniqKey="Stewart G" first="G. J." last="Stewart">G. J. Stewart</name></country><country name="Italie"><noRegion><name sortKey="Moroni, M" sort="Moroni, M" uniqKey="Moroni M" first="M." last="Moroni">M. Moroni</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Gatell, J M" sort="Gatell, J M" uniqKey="Gatell J" first="J. M." last="Gatell">J. M. Gatell</name></region></country><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Staszewski, S" sort="Staszewski, S" uniqKey="Staszewski S" first="S." last="Staszewski">S. Staszewski</name></region></country><country name="Belgique"><noRegion><name sortKey="Colebunders, R" sort="Colebunders, R" uniqKey="Colebunders R" first="R." last="Colebunders">R. Colebunders</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Hawkins, D A" sort="Hawkins, D A" uniqKey="Hawkins D" first="D. A." last="Hawkins">D. A. Hawkins</name></region><name sortKey="Johnson, M A" sort="Johnson, M A" uniqKey="Johnson M" first="M. A." last="Johnson">M. A. Johnson</name><name sortKey="Kennedy, D H" sort="Kennedy, D H" uniqKey="Kennedy D" first="D. H." last="Kennedy">D. H. Kennedy</name><name sortKey="Parkin, J M" sort="Parkin, J M" uniqKey="Parkin J" first="J. M." last="Parkin">J. M. Parkin</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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