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Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151
AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy were randomly assigned to an alternating or concurrent combination regimen of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each regimen used lower we...
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| Published in: | The Journal of infectious diseases 1994-07, Vol.170 (1), p.189-193 |
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| container_end_page | 193 |
| container_issue | 1 |
| container_start_page | 189 |
| container_title | The Journal of infectious diseases |
| container_volume | 170 |
| creator | Jacobson, Mark A. Kramer, Francoise Bassiakos, Yiannis Hooton, Thomas Polsky, Bruce Geheb, Heidi O'Donnell, James J. Walker, John D. Korvick, Joyce A. van der Horst, Charles |
| description | AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy were randomly assigned to an alternating or concurrent combination regimen of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each regimen used lower weekly cumulative doses of each drug than standard monotherapy maintenance treatment regimens. Dose-limiting toxicity attributable to foscarnet occurred in only 2 (7%) of29 evaluatable patients, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts |
| doi_str_mv | 10.1093/infdis/170.1.189 |
| format | article |
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Each regimen used lower weekly cumulative doses of each drug than standard monotherapy maintenance treatment regimens. Dose-limiting toxicity attributable to foscarnet occurred in only 2 (7%) of29 evaluatable patients, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts <500 cells/µL occurred in 11 (38%) of 29 patients, all who subsequently used adjunctive granulocyte colony-stimulating factor had severe neutropenia prevented. Severe toxicity of any type and neutropenia, in particular, occurred significantly more frequently in patients assigned to the concurrent treatment regimen. CMV was isolated from none of 21 patients who had urine cultured and from only 1 of 24 who had blood cultured while being treated during the study (median evaluation, 12 weeks). This suggests that combination therapy provides better in vivo antiviral activity in suppressing CMV replication than previously reported with monotherapy regimens.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/170.1.189</identifier><identifier>PMID: 8014496</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adolescent ; Adult ; AIDS ; AIDS-Related Opportunistic Infections - drug therapy ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Antivirals ; Biological and medical sciences ; Cell culture techniques ; Cells, Cultured ; Clinical Protocols ; Concise Comunications ; Cytomegalovirus ; Cytomegalovirus Infections - complications ; Cytomegalovirus Infections - drug therapy ; Drug Therapy, Combination ; Experimentation ; Female ; Foscarnet - therapeutic use ; Ganciclovir - therapeutic use ; Grade 3 ; Humans ; Male ; Medical sciences ; Monoclonal antibodies ; Neutropenia ; Pharmacology. Drug treatments ; Retinitis ; Retinitis - complications ; Retinitis - drug therapy ; Urine</subject><ispartof>The Journal of infectious diseases, 1994-07, Vol.170 (1), p.189-193</ispartof><rights>Copyright 1994 The University of Chicago</rights><rights>1994 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c329t-ebe7c660c96cefce293340c720282e3638b77bcd5a108273c81f07f9c80f93c53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=4183697$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8014496$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jacobson, Mark A.</creatorcontrib><creatorcontrib>Kramer, Francoise</creatorcontrib><creatorcontrib>Bassiakos, Yiannis</creatorcontrib><creatorcontrib>Hooton, Thomas</creatorcontrib><creatorcontrib>Polsky, Bruce</creatorcontrib><creatorcontrib>Geheb, Heidi</creatorcontrib><creatorcontrib>O'Donnell, James J.</creatorcontrib><creatorcontrib>Walker, John D.</creatorcontrib><creatorcontrib>Korvick, Joyce A.</creatorcontrib><creatorcontrib>van der Horst, Charles</creatorcontrib><title>Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy were randomly assigned to an alternating or concurrent combination regimen of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each regimen used lower weekly cumulative doses of each drug than standard monotherapy maintenance treatment regimens. Dose-limiting toxicity attributable to foscarnet occurred in only 2 (7%) of29 evaluatable patients, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts <500 cells/µL occurred in 11 (38%) of 29 patients, all who subsequently used adjunctive granulocyte colony-stimulating factor had severe neutropenia prevented. Severe toxicity of any type and neutropenia, in particular, occurred significantly more frequently in patients assigned to the concurrent treatment regimen. CMV was isolated from none of 21 patients who had urine cultured and from only 1 of 24 who had blood cultured while being treated during the study (median evaluation, 12 weeks). This suggests that combination therapy provides better in vivo antiviral activity in suppressing CMV replication than previously reported with monotherapy regimens.</description><subject>Adolescent</subject><subject>Adult</subject><subject>AIDS</subject><subject>AIDS-Related Opportunistic Infections - drug therapy</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Antivirals</subject><subject>Biological and medical sciences</subject><subject>Cell culture techniques</subject><subject>Cells, Cultured</subject><subject>Clinical Protocols</subject><subject>Concise Comunications</subject><subject>Cytomegalovirus</subject><subject>Cytomegalovirus Infections - complications</subject><subject>Cytomegalovirus Infections - drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Experimentation</subject><subject>Female</subject><subject>Foscarnet - therapeutic use</subject><subject>Ganciclovir - therapeutic use</subject><subject>Grade 3</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Monoclonal antibodies</subject><subject>Neutropenia</subject><subject>Pharmacology. Drug treatments</subject><subject>Retinitis</subject><subject>Retinitis - complications</subject><subject>Retinitis - drug therapy</subject><subject>Urine</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1994</creationdate><recordtype>article</recordtype><recordid>eNpFkUFvEzEQhS0EKiVw54LkA-ptW3ud2Gtu1ZamkQJEbagQF8txxo3Lrh1shxJ-JL8Jt4nCyRp_b55m5iH0lpJTSiQ7c94uXTqjotSntJHP0DEdMVFxTtlzdExIXVflW75Er1K6J4QMGRdH6KghdDiU_Bj9vdZ-GXr3B5Z4ttIJ8ATPo9MdDhbPHwK-cNZCBJ9xG_qF8zq74PFlSEZHDxmXdjzW3jjThV8u4nYVg3cGf9LOZ_CFAJ6vIOr1Fl_DnevBJ2xDxOeTixs8K3bFO-EHl1e43ebQw51-ctqkos_Ou-zSh5267UppymxPEyY8jmGzxrMYcjChw3REX6MXthB4s38H6Ovlx3l7VU2_jCft-bQyrJa5ggUIwzkxkhuwBmrJ2JAYUZO6qYFx1iyEWJjlSFPS1IKZhloirDQNsZKZERugk53vOoafG0hZ9S4Z6DrtIWySopwzUlNehGQnNDGkFMGqdXS9jltFiXqMUO0iVCVCRVXJqrS823tvFj0sDw37zAp_v-e6hNDZ-Hj9dJANacO4FP9t7lMO8YAZoWXXsu8AVTvuUobfB67jD8UFEyN19e27mk7p9PazvFG37B8AY8FJ</recordid><startdate>199407</startdate><enddate>199407</enddate><creator>Jacobson, Mark A.</creator><creator>Kramer, Francoise</creator><creator>Bassiakos, Yiannis</creator><creator>Hooton, Thomas</creator><creator>Polsky, Bruce</creator><creator>Geheb, Heidi</creator><creator>O'Donnell, James J.</creator><creator>Walker, John D.</creator><creator>Korvick, Joyce A.</creator><creator>van der Horst, Charles</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>199407</creationdate><title>Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151</title><author>Jacobson, Mark A. ; Kramer, Francoise ; Bassiakos, Yiannis ; Hooton, Thomas ; Polsky, Bruce ; Geheb, Heidi ; O'Donnell, James J. ; Walker, John D. ; Korvick, Joyce A. ; van der Horst, Charles</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c329t-ebe7c660c96cefce293340c720282e3638b77bcd5a108273c81f07f9c80f93c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1994</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>AIDS</topic><topic>AIDS-Related Opportunistic Infections - drug therapy</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Antivirals</topic><topic>Biological and medical sciences</topic><topic>Cell culture techniques</topic><topic>Cells, Cultured</topic><topic>Clinical Protocols</topic><topic>Concise Comunications</topic><topic>Cytomegalovirus</topic><topic>Cytomegalovirus Infections - complications</topic><topic>Cytomegalovirus Infections - drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Experimentation</topic><topic>Female</topic><topic>Foscarnet - therapeutic use</topic><topic>Ganciclovir - therapeutic use</topic><topic>Grade 3</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Monoclonal antibodies</topic><topic>Neutropenia</topic><topic>Pharmacology. Drug treatments</topic><topic>Retinitis</topic><topic>Retinitis - complications</topic><topic>Retinitis - drug therapy</topic><topic>Urine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jacobson, Mark A.</creatorcontrib><creatorcontrib>Kramer, Francoise</creatorcontrib><creatorcontrib>Bassiakos, Yiannis</creatorcontrib><creatorcontrib>Hooton, Thomas</creatorcontrib><creatorcontrib>Polsky, Bruce</creatorcontrib><creatorcontrib>Geheb, Heidi</creatorcontrib><creatorcontrib>O'Donnell, James J.</creatorcontrib><creatorcontrib>Walker, John D.</creatorcontrib><creatorcontrib>Korvick, Joyce A.</creatorcontrib><creatorcontrib>van der Horst, Charles</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jacobson, Mark A.</au><au>Kramer, Francoise</au><au>Bassiakos, Yiannis</au><au>Hooton, Thomas</au><au>Polsky, Bruce</au><au>Geheb, Heidi</au><au>O'Donnell, James J.</au><au>Walker, John D.</au><au>Korvick, Joyce A.</au><au>van der Horst, Charles</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>1994-07</date><risdate>1994</risdate><volume>170</volume><issue>1</issue><spage>189</spage><epage>193</epage><pages>189-193</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy were randomly assigned to an alternating or concurrent combination regimen of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each regimen used lower weekly cumulative doses of each drug than standard monotherapy maintenance treatment regimens. Dose-limiting toxicity attributable to foscarnet occurred in only 2 (7%) of29 evaluatable patients, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts <500 cells/µL occurred in 11 (38%) of 29 patients, all who subsequently used adjunctive granulocyte colony-stimulating factor had severe neutropenia prevented. Severe toxicity of any type and neutropenia, in particular, occurred significantly more frequently in patients assigned to the concurrent treatment regimen. CMV was isolated from none of 21 patients who had urine cultured and from only 1 of 24 who had blood cultured while being treated during the study (median evaluation, 12 weeks). This suggests that combination therapy provides better in vivo antiviral activity in suppressing CMV replication than previously reported with monotherapy regimens.</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>8014496</pmid><doi>10.1093/infdis/170.1.189</doi><tpages>5</tpages></addata></record> |
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| identifier | ISSN: 0022-1899 |
| ispartof | The Journal of infectious diseases, 1994-07, Vol.170 (1), p.189-193 |
| issn | 0022-1899 1537-6613 |
| language | eng |
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| source | Oxford University Press:Jisc Collections:Oxford Journal Archive: Access period 2024-2025 |
| subjects | Adolescent Adult AIDS AIDS-Related Opportunistic Infections - drug therapy Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antivirals Biological and medical sciences Cell culture techniques Cells, Cultured Clinical Protocols Concise Comunications Cytomegalovirus Cytomegalovirus Infections - complications Cytomegalovirus Infections - drug therapy Drug Therapy, Combination Experimentation Female Foscarnet - therapeutic use Ganciclovir - therapeutic use Grade 3 Humans Male Medical sciences Monoclonal antibodies Neutropenia Pharmacology. Drug treatments Retinitis Retinitis - complications Retinitis - drug therapy Urine |
| title | Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151 |
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