Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00000805
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
20 Years
Study:
NCT00000805
Study Brief:
Protocol Section:
NCT00000805