Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study

Richard J. Whitley; Gretchen Cloud; William Gruber; Gregory A. Storch; Gail J. Demmler; Richard F. Jacobs; Wayne Dankner; Stephen A. Spector; Stuart Starr; Robert F. Pass; Sergio Stagno; William J. Britt; Charles Alford; Seng Jaw Soong; Xiao Jian Zhou; Lanette Sherrill; Jan M. FitzGerald; Jean Pierre Sommadossi

doi:10.1086/516445

Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study

Richard J. Whitley, Gretchen Cloud, William Gruber, Gregory A. Storch, Gail J. Demmler, Richard F. Jacobs, Wayne Dankner, Stephen A. Spector, Stuart Starr, Robert F. Pass, Sergio Stagno, William J. Britt, Charles Alford, Seng Jaw Soong, Xiao Jian Zhou, Lanette Sherrill, Jan M. FitzGerald, Jean Pierre Sommadossi

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Abstract

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.

Original language	English
Pages (from-to)	1080-1086
Number of pages	7
Journal	Journal of Infectious Diseases
Volume	175
Issue number	5
DOIs	https://doi.org/10.1086/516445
State	Published - 1997

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Whitley, R. J., Cloud, G., Gruber, W., Storch, G. A., Demmler, G. J., Jacobs, R. F., Dankner, W., Spector, S. A., Starr, S., Pass, R. F., Stagno, S., Britt, W. J., Alford, C., Soong, S. J., Zhou, X. J., Sherrill, L., FitzGerald, J. M., & Sommadossi, J. P. (1997). Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study. Journal of Infectious Diseases, 175(5), 1080-1086. https://doi.org/10.1086/516445

@article{e97a145432af4e5abc34fb34ddd5203a,

title = "Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study",

abstract = "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.",

author = "Whitley, {Richard J.} and Gretchen Cloud and William Gruber and Storch, {Gregory A.} and Demmler, {Gail J.} and Jacobs, {Richard F.} and Wayne Dankner and Spector, {Stephen A.} and Stuart Starr and Pass, {Robert F.} and Sergio Stagno and Britt, {William J.} and Charles Alford and Soong, {Seng Jaw} and Zhou, {Xiao Jian} and Lanette Sherrill and FitzGerald, {Jan M.} and Sommadossi, {Jean Pierre}",

note = "Funding Information: Received 22 August 1996; revised 11 December 1996. Informed consent was obtained from the parents or guardians of study participants. Financial support: NIH (AI-15113, AI-62554, AI-12667, and RR-032); the state of Alabama. Reprints or correspondence: Dr. Richard J. Whitley, University of Alabama at Birmingham, Depts. of Pediatrics, Microbiology, and Medicine, 616 Children{\textquoteright}s Hospital, 1600 7th Ave. S., Birmingham, AL 35233.",

year = "1997",

doi = "10.1086/516445",

language = "English",

volume = "175",

pages = "1080--1086",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

number = "5",

}

Whitley, RJ, Cloud, G, Gruber, W, Storch, GA, Demmler, GJ, Jacobs, RF, Dankner, W, Spector, SA, Starr, S, Pass, RF, Stagno, S, Britt, WJ, Alford, C, Soong, SJ, Zhou, XJ, Sherrill, L, FitzGerald, JM & Sommadossi, JP 1997, 'Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study', Journal of Infectious Diseases, vol. 175, no. 5, pp. 1080-1086. https://doi.org/10.1086/516445

TY - JOUR

T1 - Ganciclovir treatment of symptomatic congenital cytomegalovirus infection

T2 - Results of a phase II study

AU - Whitley, Richard J.

AU - Cloud, Gretchen

AU - Gruber, William

AU - Storch, Gregory A.

AU - Demmler, Gail J.

AU - Jacobs, Richard F.

AU - Dankner, Wayne

AU - Spector, Stephen A.

AU - Starr, Stuart

AU - Pass, Robert F.

AU - Stagno, Sergio

AU - Britt, William J.

AU - Alford, Charles

AU - Soong, Seng Jaw

AU - Zhou, Xiao Jian

AU - Sherrill, Lanette

AU - FitzGerald, Jan M.

AU - Sommadossi, Jean Pierre

N1 - Funding Information: Received 22 August 1996; revised 11 December 1996. Informed consent was obtained from the parents or guardians of study participants. Financial support: NIH (AI-15113, AI-62554, AI-12667, and RR-032); the state of Alabama. Reprints or correspondence: Dr. Richard J. Whitley, University of Alabama at Birmingham, Depts. of Pediatrics, Microbiology, and Medicine, 616 Children’s Hospital, 1600 7th Ave. S., Birmingham, AL 35233.

PY - 1997

Y1 - 1997

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=16944362657&partnerID=8YFLogxK

U2 - 10.1086/516445

DO - 10.1086/516445

M3 - Article

C2 - 9129069

AN - SCOPUS:16944362657

SN - 0022-1899

VL - 175

SP - 1080

EP - 1086

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

IS - 5

ER -

Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study

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