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:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00000768
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Recommended:
* PCP prophylaxis.
Allowed:
* Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
* Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
* Recombinant human erythropoietin.
* GM-CSF and G-CSF.
* Other medications necessary for patient's welfare, at the physician's discretion.
Patients must have:
* HIV infection.
* Biopsy-proven cytomegalovirus (CMV) colitis.
* Life expectancy of at least 3 months.
* No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.
NOTE:
* Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Other etiologies for diarrhea identified at study entry.
PER AMENDMENT 3/14/95:
* For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
* Known hypersensitivity to study drugs.
* CMV retinitis.
Concurrent Medication:
Excluded:
* Acyclovir or probenecid (PER AMENDMENT 3/14/95).
* Immunomodulators.
* Biologic response modifiers (other than GM-CSF or G-CSF).
* Investigational agents, with the exception of treatment IND drugs.
* Antacids.
* H2 blockers.
* Proton pump inhibitors.
* Foscarnet during induction and pharmacokinetic part of study.
* Intravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study.
* Nephrotoxic agents.
Prior Medication:
Excluded within 14 days prior to study entry:
* Immunomodulators.
* Biologic response modifiers (other than GM-CSF or G-CSF).
* Investigational agents, with the exception of treatment IND drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000768
Study Brief:
Protocol Section:
NCT00000768