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Home > "A" Clinical Trials Conditions > An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children  An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Roche Global Development ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical acyclovir. - Consult with the Syntex study monitor for the following: - Cytokines. - Soluble CD4. - Trichosanthin (Compound Q). - Imipenem-cilastatin. - Other investigational drugs. Patients must have the following: - Congenital or acquired immune deficiency. - Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria. - Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency. Concurrent Medication: Excluded: - Other myelosuppressive drugs. - Antimetabolites. - Alkylating agents. - Nucleoside analogs (topical acyclovir is allowed). - Interferons. - Foscarnet. - Consult with the Syntex study monitor for the following: - Cytokines. - Soluble CD4. - Trichosanthin (Compound Q). - Imipenem-cilastatin. - Other investigational drugs. Patients with the following are excluded: - Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria. - Absolute neutrophil count (ANC) < 500 cells/mm3 or a platelet count < 25000 platelets/mm3. Note: - Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding. - Receiving excluded medications that it is not possible to discontinue. - Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency. - Demonstrated hypersensitivity to acyclovir or ganciclovir.
Total Enrollment: 20
Location and Contact Information:
Univ of Chicago / Wylers
Chicago, Illinois, 60637
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681983280
United States
Baylor College of Medicine / Texas Children's Hosp
Houston, Texas, 77030
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Ctr for the Health Sciences / UCLA Med Ctr
Los Angeles, California, 90095
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: 029G; ICM 1788
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002015
Other Hiv Infections Studies:
1. A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC
2. The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children with AIDS
3. A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
4. A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
5. A Study of MKC-442 in HIV-Positive Patients
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An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
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