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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT00002356
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* AIDS.
* CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
* Intolerance or resistance to other therapies.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Eligibility to participate in a controlled clinical trial of ISIS 2922.
* External ocular infection in eye to be treated.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
* Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
* Retinal detachment in eye to be treated.
* Known or suspected allergy to phosphorothioate oligonucleotides.
* Silicone oil in eye to be treated.
* Syphilis.
* Clinical evidence of retinal pigment epithelial stippling.
* Pseudoretinitis pigmentosa.
Concurrent Medication:
Excluded:
* Foscarnet.
* Mellaril, Stelazine, Thorazine, and Clofazimine.
* Ethambutol / fluconazole combination.
* Other investigational drugs 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 ganciclovir implant for treatment of CMV retinitis.
* History of intolerance to ISIS 2922.
* History of syphilis.
Required:
* Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002356
Study Brief:
Protocol Section:
NCT00002356