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 - Article
Clinical Trial: 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
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|Cytomegalovirus Infections |
| Drug: Ganciclovir ||Phase I |
MedlinePlus related topics: AIDS; Cytomegalovirus Infections
Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Expected Total Enrollment: 32
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.
Ages Eligible for Study: up to 20 Years, Genders Eligible for Study: Both
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.
- Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth.
- Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications.
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:
- 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.
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, United States
Children's Hosp of Oakland, Oakland, California, 946091809, United States
UCLA Med Ctr / Pediatric, Los Angeles, California, 900951752, United States
Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California, 900276016, United States
Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States
Children's Hosp of Denver, Denver, Colorado, 802181088, United States
Univ of Miami (Pediatric), Miami, Florida, 33161, United States
Chicago Children's Memorial Hosp, Chicago, Illinois, 606143394, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark, New Jersey, 071072198, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey, 07103, United States
Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania, 191341095, United States
Univ of Texas Galveston, Galveston, Texas, 775550435, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States
Frenkel L, Study Chair
Dankner W, Study Chair
Click here for more information about Ganciclovir
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.
Record last reviewed: August 2004
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000805
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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