Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Candidiasis, Esophageal; HIV Infections

Treatments: Drug: Amphotericin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002041

875-10

001A

Details and patient eligibility

About

To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.

Concurrent Medication:

Excluded:

• Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.

Patients with the following are excluded:

• Documented Candida fungemia.
• Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
• Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
• Patient refusal to enter study.

Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.

• Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
• Informed consent must be signed and obtained.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)