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Trial NCT00000805

Resource URI: http://static.linkedct.org/resource/trials/NCT00000805
PropertyValue
linkedct:brief_title A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
linkedct:condition <http://static.linkedct.org/resource/condition/3545>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: PER AMENDMENT 10/24/95: Allowed: - All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications. - Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity. - Amphotericin B is allowed but requires additional monitoring. Patients must have: - HIV infection. - CMV infection. - CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease. - NO loss of sight from CMV retinitis. - NO acute opportunistic infection. - Life expectancy at least to study completion. - Consent of parent or guardian. NOTE: - Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth. NOTE: - Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye. - Acute or chronic diarrhea that would affect absorption. - Clinical or laboratory toxicities of grade 3 or worse. Concurrent Medication: Excluded: - Foscarnet. - Acyclovir. - Interferon. - Myelotoxic agents for malignancy or other condition. - Other agents with anti-CMV activity. (NOTE: Enrollment of patients on IVIG must be discussed with protocol chair.) - Imipenem/cilastatin sodium. Prior Medication: Excluded within 30 days prior to study entry: - G-CSF or GM-CSF.
linkedct:description Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well. Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 20 Years
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 32 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000805
rdfs:label Trial NCT00000805
linkedct:lastchanged_date July 11, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/151057>
linkedct:location <http://static.linkedct.org/resource/location/151122>
linkedct:location <http://static.linkedct.org/resource/location/153882>
linkedct:location <http://static.linkedct.org/resource/location/153995>
linkedct:location <http://static.linkedct.org/resource/location/160713>
linkedct:location <http://static.linkedct.org/resource/location/174045>
linkedct:location <http://static.linkedct.org/resource/location/192981>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/203039>
linkedct:location <http://static.linkedct.org/resource/location/205665>
linkedct:location <http://static.linkedct.org/resource/location/209972>
linkedct:location <http://static.linkedct.org/resource/location/210066>
linkedct:location <http://static.linkedct.org/resource/location/210953>
linkedct:location <http://static.linkedct.org/resource/location/211419>
linkedct:location <http://static.linkedct.org/resource/location/213279>
linkedct:location <http://static.linkedct.org/resource/location/217340>
linkedct:location <http://static.linkedct.org/resource/location/220112>
linkedct:nct_id NCT00000805
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
linkedct:org_study_id ACTG 226
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/11658>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/18707>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000805>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/1289>
linkedct:reference <http://static.linkedct.org/resource/reference/632>
linkedct:reference <http://static.linkedct.org/resource/reference/8517>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents. SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV. Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.
rdf:type linkedct:trials
linkedct:verification_date August 2004