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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00002034
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Topical acyclovir.
* Selected cytokines.
* Allowed after the first 4 weeks of ganciclovir:
* Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.
* Other anti-retrovirals after consultation with the Syntex study monitor.
Patients must have the following:
* AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
* An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).
* Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
* Ocular conditions requiring immediate surgical correction (eg:
* retinal tear or detachment).
* Demonstrated hypersensitivity to acyclovir or ganciclovir.
* Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol.
Concurrent Medication:
Excluded:
* Antimetabolites.
* Alkylating agents.
* Nucleoside analogs (excluding selected anti-retroviral agents).
* Imipenem-cilastatin.
* Interferons.
* Selected cytokines.
* Acyclovir (except topical acyclovir).
Patients with the following are excluded:
* Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).
* Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.
Prior Medication:
Excluded within 1 month of study entry:
* Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002034
Study Brief:
Protocol Section:
NCT00002034