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

Completed · Phase 1

Conditions studied: Cytomegalovirus Infections, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000805

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

32

Expected to finish

1998-03-01

Last updated by the study team

2021-11-03

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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:
• Excluded within 30 days prior to study entry:
• G-CSF or GM-CSF.

Where it is running

• 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

Full record on ClinicalTrials.gov

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