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Follow-up assessment of subjects who received ganciclovir for CMV infections Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Follow-up assessment of subjects who received ganciclovir for CMV infections conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Follow-up assessment of subjects who received ganciclovir for CMV infections Clinical research trials and Follow-up assessment of subjects who received ganciclovir for CMV infections health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Follow-up assessment of subjects who received ganciclovir for CMV infections. Follow-up assessment of subjects who received ganciclovir for CMV infections Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Follow-up assessment of subjects who received ganciclovir for CMV infections clinical trial. Subjects frequently get the best healthcare possible for their Follow-up assessment of subjects who received ganciclovir for CMV infections condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Follow-up assessment of subjects who received ganciclovir for CMV infections  Follow-up assessment of subjects who received ganciclovir for CMV infections
Follow-up assessment of subjects who received ganciclovir for CMV infections
For Condition: Cytomegalovirus Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to document the pubertal developments and cancer histories of study subjects enrolled in the CASG protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections".
Details: 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. Ganciclovir also has been shown to be gonadal toxic in animal models. 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 14 years of age.
Eligibility:
Study Type: Observational, Retrospective Study
Minimum Age/Maximum Age: 9 Years/14 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Your child is eligible to participate in this study if he or she: Received ganciclovir during the earlier study, and if the parent or legal guardian signs an informed consent and the child signs an assent (where appropriate).
Total Enrollment: 42
Location and Contact Information:
The Hospital for Sick Children *Recruiting*
Toronto, ,
Canada
Recruiting
Sioux Valley East *Recruiting*
Sioux Falls, South Dakota, 57106
United States
Recruiting
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37232-26
United States
Recruiting
University of Alabama at Birmingham (CASG) *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
University of Alberta, Edmonton *Recruiting*
Edmonton, , T6G2B7
Canada
Recruiting
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Additional Information:
Study ID Numbers: 01-489;
Study Start Date: June 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031421
Other Cytomegalovirus Infections Studies:
1. Kinetics of response of cytomegalovirus with ganciclovir treatment using quantitative real-time PCR
2. The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients with AIDS
3. A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
4. Follow-up assessment of subjects who received ganciclovir for CMV infections
5. Immune Response to Cytomegalovirus
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other Clinical Trials
Other Edmonton Clinical Trials
Follow-up assessment of subjects who received ganciclovir for CMV infections
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