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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

Phase 2
Completed
Conditions
Candidiasis, Oral
HIV Infections
Registration Number
NCT00001065
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (32)

The Ponce de Leon Ctr. CRS

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Atlanta, Georgia, United States

Cook County Hosp. CORE Ctr.

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Chicago, Illinois, United States

Weiss Memorial Hosp.

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Chicago, Illinois, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

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Indianapolis, Indiana, United States

Massachusetts General Hospital ACTG CRS

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Boston, Massachusetts, United States

Rush Univ. Med. Ctr. ACTG CRS

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Chicago, Illinois, United States

Indiana Univ. School of Medicine, Wishard Memorial

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Indianapolis, Indiana, United States

Methodist Hosp. of Indiana

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Indianapolis, Indiana, United States

Hosp. of the Univ. of Pennsylvania CRS

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Philadelphia, Pennsylvania, United States

USC CRS

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Los Angeles, California, United States

Santa Clara Valley Med. Ctr.

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San Jose, California, United States

San Mateo County AIDS Program

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San Mateo, California, United States

Alabama Therapeutics CRS

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Birmingham, Alabama, United States

Johns Hopkins Adult AIDS CRS

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Baltimore, Maryland, United States

Puerto Rico-AIDS CRS

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San Juan, Puerto Rico

Queens Med. Ctr.

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Honolulu, Hawaii, United States

Howard University Hosp., Div. of Infectious Diseases, ACTU

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Washington, District of Columbia, United States

Univ. of Miami AIDS CRS

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Miami, Florida, United States

Univ. of Hawaii at Manoa, Leahi Hosp.

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Honolulu, Hawaii, United States

Bmc Actg Crs

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Boston, Massachusetts, United States

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

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Omaha, Nebraska, United States

Washington U CRS

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Saint Louis, Missouri, United States

SUNY - Buffalo, Erie County Medical Ctr.

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Buffalo, New York, United States

Beth Israel Med. Ctr. (Mt. Sinai)

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New York, New York, United States

NY Univ. HIV/AIDS CRS

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New York, New York, United States

Univ. of Rochester ACTG CRS

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Rochester, New York, United States

Univ. of Cincinnati CRS

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Cincinnati, Ohio, United States

The Ohio State Univ. AIDS CRS

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Columbus, Ohio, United States

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

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Mbeya, Tanzania

Northwestern University CRS

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Chicago, Illinois, United States

University of Washington AIDS CRS

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Seattle, Washington, United States

St. Louis ConnectCare, Infectious Diseases Clinic

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Saint Louis, Missouri, United States

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