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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oakland, California, United States
San Diego, California, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New York, New York, United States
Los Angeles, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
San Juan, , Puerto Rico
Los Angeles, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Paterson, New Jersey, United States
New York, New York, United States
Seattle, Washington, United States
Los Angeles, California, United States
Patients applied
Trial Officials
Frenkel L
Study Chair
Dankner W
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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