Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study
Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical...
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| Veröffentlicht in: | The Journal of infectious diseases 1997-05, Vol.175 (5), p.1080-1086 |
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| container_title | The Journal of infectious diseases |
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| creator | Whitley, Richard J. Cloud, Gretchen Gruber, William Storch, Gregory A. Demmler, Gail J. Jacobs, Richard F. Dankner, Wayne Spector, Stephen A. Starr, Stuart Pass, Robert F. Stagno, Sergio Britt, William J. Alford, Charles Soong, Seng-jaw Zhou, Xiao-Jian Sherrill, Lanette FitzGerald, Jan M. Sommadossi, Jean-Pierre |
| description | Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy. |
| doi_str_mv | 10.1086/516445 |
| format | Article |
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A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/516445</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; Children ; Cytomegalovirus ; Cytomegalovirus infections ; Dosage ; Health care administration ; Infants ; Infections ; Major Articles ; Medical sciences ; Pharmacokinetics ; Pharmacology. Drug treatments ; Platelets ; Urine</subject><ispartof>The Journal of infectious diseases, 1997-05, Vol.175 (5), p.1080-1086</ispartof><rights>Copyright 1997 The University of Chicago</rights><rights>1997 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press May 1997</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-9fee27eecf8641176d821ea514e8a64922f8120d4f2743e1c98d0c15e4821cd3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/30132632$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/30132632$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,776,780,799,27903,27904,57996,58229</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2660417$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Whitley, Richard J.</creatorcontrib><creatorcontrib>Cloud, Gretchen</creatorcontrib><creatorcontrib>Gruber, William</creatorcontrib><creatorcontrib>Storch, Gregory A.</creatorcontrib><creatorcontrib>Demmler, Gail J.</creatorcontrib><creatorcontrib>Jacobs, Richard F.</creatorcontrib><creatorcontrib>Dankner, Wayne</creatorcontrib><creatorcontrib>Spector, Stephen A.</creatorcontrib><creatorcontrib>Starr, Stuart</creatorcontrib><creatorcontrib>Pass, Robert F.</creatorcontrib><creatorcontrib>Stagno, Sergio</creatorcontrib><creatorcontrib>Britt, William J.</creatorcontrib><creatorcontrib>Alford, Charles</creatorcontrib><creatorcontrib>Soong, Seng-jaw</creatorcontrib><creatorcontrib>Zhou, Xiao-Jian</creatorcontrib><creatorcontrib>Sherrill, Lanette</creatorcontrib><creatorcontrib>FitzGerald, Jan M.</creatorcontrib><creatorcontrib>Sommadossi, Jean-Pierre</creatorcontrib><creatorcontrib>National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group</creatorcontrib><creatorcontrib>the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group</creatorcontrib><title>Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.</description><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Children</subject><subject>Cytomegalovirus</subject><subject>Cytomegalovirus infections</subject><subject>Dosage</subject><subject>Health care administration</subject><subject>Infants</subject><subject>Infections</subject><subject>Major Articles</subject><subject>Medical sciences</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. 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Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Children</topic><topic>Cytomegalovirus</topic><topic>Cytomegalovirus infections</topic><topic>Dosage</topic><topic>Health care administration</topic><topic>Infants</topic><topic>Infections</topic><topic>Major Articles</topic><topic>Medical sciences</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. 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A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><doi>10.1086/516445</doi><tpages>7</tpages></addata></record> |
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| ispartof | The Journal of infectious diseases, 1997-05, Vol.175 (5), p.1080-1086 |
| issn | 0022-1899 1537-6613 |
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| source | Jstor Complete Legacy; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences Children Cytomegalovirus Cytomegalovirus infections Dosage Health care administration Infants Infections Major Articles Medical sciences Pharmacokinetics Pharmacology. Drug treatments Platelets Urine |
| title | Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study |
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