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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00002156
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* AIDS.
* CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
* No more than one previous progression of CMV retinitis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions in the eye to be treated are excluded:
* External ocular infection.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
* Ocular condition that will obstruct visualization of the posterior ocular structures.
* Retinal detachment.
* Silicone oil in eye.
Patients with the following other symptoms or conditions are excluded:
* Known or suspected allergy to phosphorothioate oligonucleotides.
* Syphilis.
* Retinal pigment epithelial stippling not associated with CMV retinitis.
* Pseudoretinitis pigmentosa.
* Chronic diarrhea that would impair absorption of oral ganciclovir.
* Intolerance to ganciclovir.
Concurrent Medication:
Excluded:
* Foscarnet or other anti-CMV agents other than ganciclovir.
* Mellaril.
* Stelazine.
* Thorazine.
* Clofazimine.
* Ethambutol/fluconazole combination.
* Investigational medications for CMV retinitis.
Concurrent Treatment:
Excluded:
* Investigational procedures for CMV retinitis.
Patients with the following prior conditions are excluded:
* History of surgery to correct retinal detachment in eye to be treated.
* History of intolerance to ISIS 2922.
Prior Medication:
Excluded:
* Prior ganciclovir implant for CMV retinitis.
* More than 4 months of prior ganciclovir.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002156
Study Brief:
Protocol Section:
NCT00002156