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
2 other identifiers
interventional
32
2 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- PER AMENDMENT 10/24/95: Allowed:
- 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:
- +1 more criteria
You may not qualify if:
- 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:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, 90027, United States
Usc La Nichd Crs
Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 94609, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92093, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90502, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, 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, 10032, United States
Incarnation Children's Ctr.
New York, New York, 10032, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134, 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
Related Publications (3)
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)
BACKGROUNDFrenkel 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)
BACKGROUNDFrenkel 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.
PMID: 11069232BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frenkel L
- STUDY CHAIR
Dankner W