Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Completed · Not applicable
Conditions studied: Candidiasis, Esophageal, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002041
- Run by
- Bristol-Myers Squibb
- Last updated by the study team
- 2007-10-02
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Bristol - Myers Squibb Co — Princeton, New Jersey, United States
Full record on ClinicalTrials.gov
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