NCT00002041

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 2, 2007

Status Verified

October 1, 2007

First QC Date

November 2, 1999

Last Update Submit

October 1, 2007

Conditions

Candidiasis, EsophagealHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsEsophagitisAcquired Immunodeficiency SyndromeAmphotericin BCandidiasis, Oral

Interventions

Amphotericin BDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol - Myers Squibb Co

Princeton, New Jersey, 085434000, United States

Location

MeSH Terms

Conditions

CandidiasisHIV InfectionsAIDS-Related Opportunistic InfectionsEsophagitisAcquired Immunodeficiency SyndromeCandidiasis, Oral

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisSlow Virus DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

October 2, 2007

Record last verified: 2007-10

Locations

US(1)