Completed

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

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
NCT00000805
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornMultiple Acyl Coenzyme A Dehydrogenase Deficiency

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy

Los Angeles, United StatesOpen Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy in Google Maps
Suspended

Usc La Nichd Crs

Los Angeles, United States
Suspended

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, United States
Suspended

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, United States
Completed19 Study Centers
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 | PatLynk