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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Candidiasis, Esophageal HIV Infections

Keywords

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Candidiasis, Oral AIDS-Related Opportunistic Infections Esophagitis Acquired Immunodeficiency Syndrome Amphotericin B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amphotericin B

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Bristol - Myers Squibb Co

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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875-10

Identifier Type: -

Identifier Source: secondary_id

001A