Completed

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

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What is being tested

Amphotericin B

Drug
Who is being recruted

Candidiasis, Oral

+ HIV Infections
Over 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

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. Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging. Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.

Official TitleA Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
70 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Candidiasis, Oral
HIV Infections
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 32 locations
Suspended
Alabama Therapeutics CRSBirmingham, United StatesSee the location
Suspended
USC CRSLos Angeles, United States
Suspended
Santa Clara Valley Med. Ctr.San Jose, United States
Suspended
San Mateo County AIDS ProgramSan Mateo, United States
Completed32 Study Centers
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 | PatLynk