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 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT00002095
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Topical or ophthalmic nucleoside analogs.
Patients must have:
* Confirmation of HIV infection.
* Documented CMV infection.
* No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
* Adequate visualization of the retina of both eyes by ophthalmologist.
* CD4 count \<= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count \<= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
* Inability to comply with protocol.
Concurrent Medication:
Excluded:
* The following nucleoside analogs:
* IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses \> 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
* FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
* Imipenem-cilastatin (Primaxin).
Patients with the following prior condition are excluded:
History of hypersensitivity to acyclovir.
Prior Medication:
Excluded within the past 60 days:
Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002095
Study Brief:
Protocol Section:
NCT00002095