Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial
Identifieur interne : 006C33 ( PascalFrancis/Curation ); précédent : 006C32; suivant : 006C34Efficacy 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.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
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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></affiliation><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Boucher, C A B" sort="Boucher, C A B" uniqKey="Boucher C" first="C. A. 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Staszewski</name><affiliation wicri:level="1"><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></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></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="1"><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></affiliation><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></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="1"><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></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></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="1"><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></affiliation><affiliation wicri:level="1"><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></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></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></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></affiliation><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></affiliation></author><author><name sortKey="Joly, V" sort="Joly, V" uniqKey="Joly V" first="V." last="Joly">V. Joly</name><affiliation wicri:level="1"><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></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="1"><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></affiliation></author><author><name sortKey="Jost, J" sort="Jost, J" uniqKey="Jost J" first="J." last="Jost">J. Jost</name><affiliation wicri:level="1"><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></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="1"><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></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></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="1"><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></affiliation></author><author><name sortKey="Staszewski, S" sort="Staszewski, S" uniqKey="Staszewski S" first="S." last="Staszewski">S. Staszewski</name><affiliation wicri:level="1"><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></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></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="1"><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></affiliation><affiliation wicri:level="1"><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></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="1"><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></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="1"><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></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="1"><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></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></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="1"><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></affiliation><affiliation wicri:level="1"><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></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></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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0924-8579</s0></fA01><fA03 i2="1"><s0>Int. j. antimicrob. agents</s0></fA03><fA05><s2>11</s2></fA05><fA06><s2>1</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Efficacy and safety of combination therapy with delavirdine and zidovudine : a European/Australian phase II trial</s1></fA08><fA11 i1="01" i2="1"><s1>BEEN-TIKTAK (A. M. M.)</s1></fA11><fA11 i1="02" i2="1"><s1>BOUCHER (C. A. B.)</s1></fA11><fA11 i1="03" i2="1"><s1>BRUN-VEZINET (F.)</s1></fA11><fA11 i1="04" i2="1"><s1>JOLY (V.)</s1></fA11><fA11 i1="05" i2="1"><s1>MULDER (J. W.)</s1></fA11><fA11 i1="06" i2="1"><s1>JOST (J.)</s1></fA11><fA11 i1="07" i2="1"><s1>COOPER (D. A.)</s1></fA11><fA11 i1="08" i2="1"><s1>MORONI (M.)</s1></fA11><fA11 i1="09" i2="1"><s1>GATELL (J. M.)</s1></fA11><fA11 i1="10" i2="1"><s1>STASZEWSKI (S.)</s1></fA11><fA11 i1="11" i2="1"><s1>COLEBUNDERS (R.)</s1></fA11><fA11 i1="12" i2="1"><s1>STEWART (G. J.)</s1></fA11><fA11 i1="13" i2="1"><s1>HAWKINS (D. A.)</s1></fA11><fA11 i1="14" i2="1"><s1>JOHNSON (M. A.)</s1></fA11><fA11 i1="15" i2="1"><s1>PARKIN (J. M.)</s1></fA11><fA11 i1="16" i2="1"><s1>KENNEDY (D. H.)</s1></fA11><fA11 i1="17" i2="1"><s1>HOY (J. F.)</s1></fA11><fA11 i1="18" i2="1"><s1>BORLEFFS (J. C. C.)</s1></fA11><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></fA14><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></fA14><fA14 i1="03"><s1>Department of Virology, Bichat-Claude Bernard Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Internal Medicine, Bichat-Claude Bernard Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Internal Medicine, Slotervaart Hospital</s1><s2>Amsterdam</s2><s3>NLD</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Department of Infectious Diseases, University Hospital</s1><s2>Zürich</s2><s3>CHE</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>HIV Medicine Unit, St Vincent's Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Clinic of Infectious Diseases, Sant'Orsola Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Servicio de Infecciones, Hospital Clinic i Provincial</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>Department of Infectious Diseases, Goethe University Hospital</s1><s2>Frankfurt</s2><s3>DEU</s3><sZ>10 aut.</sZ></fA14><fA14 i1="11"><s1>Institute of Tropical Medicine</s1><s2>Antwerp</s2><s3>BEL</s3><sZ>11 aut.</sZ></fA14><fA14 i1="12"><s1>Department of Clinical Immunology, Westmead Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>12 aut.</sZ></fA14><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></fA14><fA14 i1="14"><s1>St. Stephen Centre, Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></fA14><fA14 i1="15"><s1>Department of Thoracic Surgery, Royal Free Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>14 aut.</sZ></fA14><fA14 i1="16"><s1>Department of Immunology, St. Bartholomews Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>15 aut.</sZ></fA14><fA14 i1="17"><s1>Department of Infection and Tropical Medicine, Ruchill Hospital</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>16 aut.</sZ></fA14><fA14 i1="18"><s1>Department of Microbiology and Infectious Diseases, Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>17 aut.</sZ></fA14><fA20><s1>13-21</s1></fA20><fA21><s1>1999</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>22211</s2><s5>354000073720800030</s5></fA43><fA44><s0>0000</s0><s1>© 1999 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>39 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>99-0157901</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>International journal of antimicrobial agents</s0></fA64><fA66 i1="01"><s0>NLD</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02S05</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Délavirdine</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Delavirdine</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Delavirdina</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Zidovudine</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Zidovudine</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Zidovudina</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Antiviral</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Antiviral</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Antiviral</s0><s5>07</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Enzyme inhibitor</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Inhibidor enzima</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>RNA-directed DNA polymerase</s0><s2>FE</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>RNA-directed DNA polymerase</s0><s2>FE</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>RNA-directed DNA polymerase</s0><s2>FE</s2><s5>11</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>SIDA</s0><s5>13</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>AIDS</s0><s5>13</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>SIDA</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Association médicamenteuse</s0><s5>14</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Drug combination</s0><s5>14</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Asociación medicamentosa</s0><s5>14</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Traitement</s0><s5>16</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Treatment</s0><s5>16</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Tratamiento</s0><s5>16</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Chimiothérapie</s0><s5>17</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Chemotherapy</s0><s5>17</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Quimioterapia</s0><s5>17</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Efficacité traitement</s0><s5>18</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Treatment efficiency</s0><s5>18</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Eficacia tratamiento</s0><s5>18</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Toxicité</s0><s5>19</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Toxicity</s0><s5>19</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Toxicidad</s0><s5>19</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Homme</s0><s5>20</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Human</s0><s5>20</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Hombre</s0><s5>20</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Pyrimidine nucléoside</s0><s5>27</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Pyrimidine nucleoside</s0><s5>27</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Pirimidina nucleósido</s0><s5>27</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Didésoxynucléoside</s0><s5>28</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>Dideoxynucleoside</s0><s5>28</s5></fC03><fC03 i1="14" i2="X" l="SPA"><s0>Didesoxinucleósido</s0><s5>28</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Nucleotidyltransferases</s0><s2>FE</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Nucleotidyltransferases</s0><s2>FE</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Nucleotidyltransferases</s0><s2>FE</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Enzyme</s0></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Enzyme</s0></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enzima</s0></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Virose</s0></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Viral disease</s0></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Virosis</s0></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Infection</s0></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Infection</s0></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Infección</s0></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Immunopathologie</s0><s5>69</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Immunopathology</s0><s5>69</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Inmunopatología</s0><s5>69</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Immunodéficit</s0><s5>70</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Immune deficiency</s0><s5>70</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Inmunodeficiencia</s0><s5>70</s5></fC07><fN21><s1>095</s1></fN21></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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