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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT00002134
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Topical drugs and ophthalmics.
Patients must have:
* AIDS.
* Unilateral CMV retinitis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
* Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
* Acute retinal necrosis or any other intraocular condition that might preclude study completion.
* Ocular condition requiring immediate surgery.
* Unable to have long-term IV catheter placement.
Concurrent Medication:
Excluded:
* Vidarabine.
* Amantadine hydrochloride.
* Cytarabine.
* FIAC or FIAU.
* Idoxuridine.
* Ribavirin.
* Valacyclovir.
* Foscarnet.
* CMV hyperimmune globulin.
* Soluble CD4.
* Trichosanthin.
* Imipenem-cilastatin.
* Isoprinosine.
* Levamisole.
* Interferon.
* Other investigational drugs.
Patients with the following prior conditions are excluded:
* History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
* History of hypersensitivity to acyclovir or ganciclovir.
Prior Medication:
Excluded:
* Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
* Prior intravitreal ganciclovir implant.
* More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
* Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002134
Study Brief:
Protocol Section:
NCT00002134