Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Esophageal; HIV Infections
Intervention: Amphotericin B (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .
Summary
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.
Clinical Details
Official title: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Bristol - Myers Squibb Co, Princeton, New Jersey 085434000, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: October 1, 2007
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