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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00004794
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Acquired immunodeficiency syndrome (AIDS) Meets Centers for Disease Control and Prevention definition
* Peripheral cytomegalovirus (CMV) retinitis Diagnosed by ophthalmologist certified by the Study of Ocular Complications of AIDS group At least 1 lesion measuring at least 25% of disc on photograph No lesion within zone 1 No lesion involving 25% or more of retina regardless of location
* Visual acuity in affected eye 3 or more lines on the Early Treatment Diabetic Retinopathy Study chart at 1 meter Snellen equivalent 8/200
* No retinal detachment in affected eye
* No media opacity that precludes visualization of fundus in both eyes
* No extraocular CMV disease
--Prior/Concurrent Therapy--
* No prior or concurrent anti-CMV therapy, i.e.: Ganciclovir Foscarnet CMV hyperimmune immunoglobulin Other investigational agents with anti-CMV activity
* Prior CMV prophylaxis allowed
* At least 7 days since nephrotoxic drugs, including: Amphotericin B Vidarabine Aminoglycoside antibiotics Intravenous pentamidine
--Patient Characteristics--
* Age: 13 to 60
* Performance status: Karnofsky 60%-100%
* Hematopoietic: ANC at least 750 Platelets at least 50,000 Hemoglobin greater than 7.5 g/dL
* Hepatic: Bilirubin no greater than 3.0 mg/dL Transaminases no greater than 5 times normal
* Renal: Creatinine no greater than 1.5 mg/dL Proteinuria less than 1+ No clinically significant renal disease No dialysis
* Cardiovascular: No clinically significant cardiac disease, including: Ischemia Congestive heart failure Arrhythmia
* Other:
No probenecid allergy No medical problems sufficient to hinder compliance with therapy or follow- up, including drug or alcohol abuse No pregnant or nursing women Negative serum pregnancy test required of fertile women Adequate birth control required of fertile patients during and for 3 months after study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
60 Years
Study:
NCT00004794
Study Brief:
Protocol Section:
NCT00004794