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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00002041

First received: November 2, 1999
Last updated: October 1, 2007
Last Verified: October 2007
History of Changes
Purpose

Purpose

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.

Condition Intervention
Candidiasis, Esophageal
HIV Infections

Drug : Amphotericin B

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

Further study details as provided by Bristol-Myers Squibb:

Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002041

Locations

United States, New Jersey
Bristol - Myers Squibb Co
Princeton, New Jersey, United States, 085434000

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Principal Investigator: . .
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00002041   History of Changes  
Other Study ID Numbers: 001A  
  875-10  
Study First Received: November 2, 1999  
Last Updated: October 1, 2007  

Keywords provided by Bristol-Myers Squibb:

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

Additional relevant MeSH terms:
HIV Infections
Esophagitis
Candidiasis
Amphotericin B
Liposomal amphotericin B

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.