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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT00000693
Eligibility Criteria:
Inclusion Criteria
Prior Medication:
Required:
* Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction.
Amended to allow:
* Investigational triazoles.
* Human recombinant erythropoietin (Eprex).
* Other investigational non-antiviral therapies offered through treatment IND.
Patients must:
* Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot
* Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye.
* Be capable of signing an informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Known or suspected allergy to one of the study medications.
* Inability to maintain adequate hydration status.
Concurrent Medication:
Excluded:
* Concurrent therapy with nephrotoxic agents.
* Systemic therapy for another opportunistic infection.
* Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP).
* Probenecid.
* Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments.
Patients with the following are excluded:
* Known or suspected allergy to one of the study medications.
* Inability to maintain adequate hydration status.
Prior Medication:
Excluded within 2 weeks of study entry:
* Steroids.
* Cytotoxic or immunosuppressive drugs.
* Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir).
Prior Treatment:
Excluded within 2 weeks of study entry:
* Radiotherapy.
Risk Behavior:
Excluded:
* History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000693
Study Brief:
Protocol Section:
NCT00000693