A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Pati… (NCT00001065) | Clinical Trial Compass
CompletedPhase 2
A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole
United States, Puerto Rico, Tanzania70 participants
Plain-language summary
To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
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
Patients must have:
* HIV infection OR diagnosis of AIDS.
* Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.
* Perioral lesions only (e.g., angular stomatitis, perleche).
* Inability to swish and swallow oral solution.
* Inability to tolerate further oral therapy for thrush.
Concurrent Medication:
Excluded:
* Fluconazole.
* Itraconazole.
* Ketoconazole.
* Flucytosine.
* Intravenous amphotericin or other non-study formulations.
* Nystatin.
* Clotrimazole.
* Other investigational antifungal agents.
* Systemic cytotoxic chemotherapy for malignancy.
Concurrent Treatment:
Excluded:
* Radiation therapy to the mouth, neck, or chest.
Patients with the following prior conditions are excluded:
* Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.
* Successful treatment of thrush with fluconazole at \<= 200 mg/day after original treatment failure.
* History of oral candidiasis that recurred or persisted despite IV amphotericin B given once or more weekly.
* History of anaphylaxis to amphotericin B.
* History of hypersensitivity to components in amphotericin B oral suspension.
Prior Medication:
Excluded within 6 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 IDNCT00001065
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)