Neonatal CMV-Ganciclovir Follow-up Study
The purpose of this study is to document the developments associated with puberty and determine if any of the children who previously participated in another research study have been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group (CASG) protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections." One of the medications used in this study to treat cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development of gonads (ovaries in females and testes in males) when administered to animals. Children, 9-14 years old, who participated in the previous research study, will participate in this study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following procedures performed: a complete physical examination, a single blood sample collected, an x-ray of the left wrist.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||A Follow-up Assessment of Subjects Who Received Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) During the Phase I/II Study to Evaluate the Safety and Efficacy of Ganciclovir Treatment for Congenital Cytomegalovirus (CMV) Infections|
- Sexual Development. [ Time Frame: Analysis. ] [ Designated as safety issue: No ]
- Pubertal Status. [ Time Frame: Analysis. ] [ Designated as safety issue: No ]
- Cancer Incidence. [ Time Frame: Analysis. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||November 2005|
16 received ganciclovir at 8 mg/kg/day in the previous study.
31 received ganciclovir at 12 mg/kg/day in the previous study.
Ganciclovir has been shown to be carcinogenic, teratogenic, and gonadal toxic in animal models. Mice treated with ganciclovir experienced an increase in the incidence of tumors of the preputial gland (males), harderian gland (males), forestomach (males and females), ovaries (females), uterus (females), mammary gland (females), clitoral gland (females), vagina (females), and liver (females). While the preputial and clitoral glands, forestomach, and harderian glands of mice do not have human counterparts, ganciclovir is considered a potential carcinogen in humans. Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility, possibly due to inhibition of rapidly dividing cell populations including spermatogonia. In the animal models, these effects were reversible at lower doses and irreversible at higher doses. In both male and female mice, ganciclovir has been shown to cause decreased fertility. Gonadal toxicity in rats, mice, and dogs included testicular atrophy in males and, more variable, ovarian atrophy in females. There are no data in humans that demonstrate these effects following treatment with ganciclovir. This study seeks to formally establish the overall sexual development, cancer incidence, and pubertal status of those study subjects who previously received six weeks of ganciclovir as they now approach puberty. The original study was performed from 1986 to 1991, and therefore subjects who were enrolled are now nine to fourteen years of age.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031421
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|