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Sponsored by: |
Roche Global Development |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002015 |
To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.
Condition | Intervention |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children |
Ages Eligible for Study: | 3 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Ctr for the Health Sciences / UCLA Med Ctr | |
Los Angeles, California, United States, 90095 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
Children's Hosp of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Illinois | |
Univ of Chicago / Wylers | |
Chicago, Illinois, United States, 60637 | |
United States, Nebraska | |
Univ of Nebraska Med Ctr | |
Omaha, Nebraska, United States, 681983280 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Texas | |
Baylor College of Medicine / Texas Children's Hosp | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | 029G, ICM 1788 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002015 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Retinitis Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Immunocompromised Host |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Antiviral Agents Cytomegalovirus |
Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections Retinal Diseases |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |