The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eye… (NCT00001034) | Clinical Trial Compass
CompletedPhase 2
The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
United States850 participants
Plain-language summary
To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression.
The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.
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:
* Antiretroviral therapy.
* Anti-PCP prophylaxis.
* Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.
Patients must have:
* Working diagnosis of HIV infection.
* CD4 count \<= 100 cells/mm3.
* Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
* Reasonably good health.
* Life expectancy of at least 6 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Acute life-threatening illness.
* Active lymphoma.
* Hypersensitivity to acyclovir.
* Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.
Concurrent Medication:
Excluded:
* Vidarabine.
* Amantadine hydrochloride (Symmetrel).
* CMV hyperimmune globulin/intravenous immune globulin.
* Cytarabine.
* Fiacitabine (FIAC) or fialuridine (FIAU).
* Foscarnet.
* Intravenous ganciclovir.
* HPMPC.
* Idoxuridine.
* Intravenous acyclovir.
* Oral acyclovir at \> 1 g/day.
* Other drugs with potential anti-CMV activity.
Prior Medication:
Excluded within 60 days prior to study entry:
* Foscarnet.
Excluded within 2 weeks prior to study entry:
* Vidarabine.
* Amantadine hydrochloride (Symmetrel).
* CMV hyperimmune globulin/intravenous immune globulin.
* Cytarabine.
* Fiacitabine (FIAC) or fialuridine (FIAU).
* Ganciclovir.
* HPMPC.
* Idoxuridine.
* Intravenous acycl…
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 IDNCT00001034
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)