A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intraveno… (NCT00000768) | Clinical Trial Compass
CompletedPhase 1
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
United States24 participants
Plain-language summary
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir.
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
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:
Recommended:
* PCP prophylaxis.
Allowed:
* Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
* Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
* Recombinant human erythropoietin.
* GM-CSF and G-CSF.
* Other medications necessary for patient's welfare, at the physician's discretion.
Patients must have:
* HIV infection.
* Biopsy-proven cytomegalovirus (CMV) colitis.
* Life expectancy of at least 3 months.
* No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.
NOTE:
* Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Other etiologies for diarrhea identified at study entry.
PER AMENDMENT 3/14/95:
* For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
* Known hypersensitivity to study drugs.
* CMV retinitis.
Concurrent Medication:
Excluded:
* Acyclovir or probenecid (PER AMENDMENT 3/14/95).
* Immunomodulators.
* Biologic response modifiers (other than GM-CSF or G-CSF).
* Investigational agents, with the exception of treatment IND drugs.
* Antaci…
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 IDNCT00000768
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)