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

HIV Infections Clinical Trial

Official title:

A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001065
• Other study ID #: ACTG 295
• Secondary ID: 11271
• Status: Completed
• Phase: Phase 2
• Est. completion date: April 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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:

• Cytotoxic therapy for malignancy.
• Corticosteroids at higher than replacement doses.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections
• Infections

Intervention

Drug:
• Amphotericin B

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico-AIDS CRS	San Juan
Tanzania	Mbeya Med. Research Program, Mbeya Referral Hosp. CRS	Mbeya
United States	The Ponce de Leon Ctr. CRS	Atlanta	Georgia
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	Bmc Actg Crs	Boston	Massachusetts
United States	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts
United States	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York
United States	Cook County Hosp. CORE Ctr.	Chicago	Illinois
United States	Northwestern University CRS	Chicago	Illinois
United States	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois
United States	Weiss Memorial Hosp.	Chicago	Illinois
United States	Univ. of Cincinnati CRS	Cincinnati	Ohio
United States	The Ohio State Univ. AIDS CRS	Columbus	Ohio
United States	Queens Med. Ctr.	Honolulu	Hawaii
United States	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii
United States	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	Indiana Univ. School of Medicine, Wishard Memorial	Indianapolis	Indiana
United States	Methodist Hosp. of Indiana	Indianapolis	Indiana
United States	USC CRS	Los Angeles	California
United States	Univ. of Miami AIDS CRS	Miami	Florida
United States	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York
United States	NY Univ. HIV/AIDS CRS	New York	New York
United States	Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.	Omaha	Nebraska
United States	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania
United States	Univ. of Rochester ACTG CRS	Rochester	New York
United States	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri
United States	Washington U CRS	Saint Louis	Missouri
United States	Santa Clara Valley Med. Ctr.	San Jose	California
United States	San Mateo County AIDS Program	San Mateo	California
United States	University of Washington AIDS CRS	Seattle	Washington
United States	Howard University Hosp., Div. of Infectious Diseases, ACTU	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico,  Tanzania,