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
NCT ID: NCT00000805
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Days
20 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Frenkel L
Role: STUDY_CHAIR
Dankner W
Role: STUDY_CHAIR
Locations
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Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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Capparelli EV, Frenkel LM, Dankner W, Wei LJ, Xu J, Spector S, Connor J, Ballow A, Mohan K, Robinson C, Shaver A, Rich K, Thompson M, Read J, Wirkus C, Balsley J, Culnane M, Mcintosh K. Population pharmacokinetics of oral and intravenous ganciclovir (GCV) in HIV and CMV infected children. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:10 (abstract no A51)
Frenkel LM, Dankner W, Capparelli E, Wei LJ, Xu J, Spector S, Connor J, Ballow A, Mohan K, Robinson C, Shaver A, Rich K, Thompson M, Read J, Wirkus C, Balsley J, Culnane M, McIntosh K. A pharmacokinetic (PK) study of oral ganciclovir (GCV) in HIV- and cytomegalovirus (CMV)- infected children. Int Conf AIDS. 1996 Jul 7-12;11(2):31 (abstract no WeB550)
Frenkel LM, Capparelli EV, Dankner WM, Xu J, Smith IL, Ballow A, Culnane M, Read JS, Thompson M, Mohan KM, Shaver A, Robinson CA, Stempien MJ, Burchett SK, Melvin AJ, Borkowsky W, Petru A, Kovacs A, Yogev R, Goldsmith J, McFarland EJ, Spector SA. Oral ganciclovir in children: pharmacokinetics, safety, tolerance, and antiviral effects. The Pediatric AIDS Clinical Trials Group. J Infect Dis. 2000 Dec;182(6):1616-24. doi: 10.1086/317600. Epub 2000 Nov 8.
Other Identifiers
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11203
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 226
Identifier Type: -
Identifier Source: org_study_id