A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes (NCT00001062) | Clinical Trial Compass
CompletedPhase 1
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
United States25 participants
Plain-language summary
To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients.
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Concurrent Medication:
Allowed:
* Erythropoietin, G-CSF, or GM-CSF.
* Antiretrovirals.
Patients must have:
* HIV infection.
* Evaluable CMV retinitis with photographable lesions.
* Life expectancy of at least 6 months.
* No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
* Corneal, lens, or vitreous opacification precluding funduscopic exam.
* Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
* Inability to obtain temporary IV access.
* Requirement for permanent catheters for IV ganciclovir administration.
* Uncontrolled diarrhea or nausea preventing ingestion of medicine.
* Known hypersensitivity to IV or oral ganciclovir.
Concurrent Medication:
Excluded:
* Immunomodulators.
* Biologic response modifiers.
* Interferon.
* Related investigational agents.
* CMV prophylaxis.
* Systemic acyclovir.
* Any nephrotoxic agent.
* Any concomitant therapy that would prohibit use of ganciclovir.
Prior Medication:
Excluded:
* Prior treatment for CMV retinitis.
* More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001062
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)