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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


N/A
9 Years
14 Years
Not Enrolling
Both
Cytomegalovirus Infections

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Trial Information

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


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.


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"

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Sexual Development.

Outcome Time Frame:

Analysis.

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

01-489

NCT ID:

NCT00031421

Start Date:

September 2001

Completion Date:

November 2005

Related Keywords:

  • Cytomegalovirus Infections
  • CMV, cytomegalovirus, children, ganciclovir
  • Cytomegalovirus Infections

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300