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OpenTrials
Completed

NCT Number: NCT00002041

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

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.

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Key information

Conditions

Candidiasis, Esophageal AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Candidiasis Candidiasis, Oral Communicable Diseases Digestive System Diseases Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mouth Diseases Mycoses Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol - Myers Squibb Co

Princeton, New Jersey, 085434000, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amphotericin B

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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