Neonatal CMV-Ganciclovir Follow-up Study
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Infections
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Clinical Details
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
Study design: Other
Detailed description:
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.
Eligibility
Minimum age: 9 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Children who received ganciclovir during the earlier study ("Evaluation of Ganciclovir
(DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections), and if the
parent or legal guardian signs an informed consent and the child signs an assent (where
appropriate).
Exclusion Criteria:
Any individuals not previously enrolled in the CASG protocol titled "Evaluation of
Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections"
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Additional Information
Starting date: September 2001
Ending date: November 2005
Last updated: January 24, 2008
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