A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

NCT00002339

Last updated date
Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Candidiasis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients must have:

- AIDS or other immunocompromising condition.

- Candidal esophagitis.

- Life expectancy of at least 2 months.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Co-existing Condition:


Patients with the following symptoms or conditions are excluded:


- Evidence of non-candidal systemic fungal infection.


- Abnormalities that may preclude esophagoscopy or endoscopy.


- Unable to tolerate fluconazole.


- Unable to give informed consent.


- Enrollment in other experimental trials of approved or non-approved drugs or systemic
compounds (unless approved by the Pfizer Clinical Monitor).


- Other condition that would make patient unsuitable for enrollment.


Concurrent Medication:


Excluded:


- Concomitant oral or topical antifungal agent.


- Other experimental medications.


Patients with the following prior condition are excluded:


History of allergy to imidazoles or azoles.


Prior Medication:


Excluded:


- Any oral or topical antifungal therapy within the past 3 days. Active use of illicit
or illegal drugs.

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Esophageal Candidiasis, HIV InfectionsA Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems NCT00002339
  1. Los Angeles, California
  2. Houston, Texas
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official Title  ICMJE An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Brief Summary To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
Detailed Description Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis, Esophageal
  • HIV Infections
Intervention  ICMJE Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications * Agresti MG, de Bernardis F, Mondello F, Bellocco R, Carosi GP, Caputo RM, Milazzo F, Chiodo F, Giannini V, Minoli L, et al. Clinical and mycological evaluation of fluconazole in the secondary prophylaxis of esophageal candidiasis in AIDS patients. An open, multicenter study. Eur J Epidemiol. 1994 Feb;10(1):17-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Patients must have:

  • AIDS or other immunocompromising condition.
  • Candidal esophagitis.
  • Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Evidence of non-candidal systemic fungal infection.
  • Abnormalities that may preclude esophagoscopy or endoscopy.
  • Unable to tolerate fluconazole.
  • Unable to give informed consent.
  • Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
  • Other condition that would make patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

  • Concomitant oral or topical antifungal agent.
  • Other experimental medications.

Patients with the following prior condition are excluded:

History of allergy to imidazoles or azoles.

Prior Medication:

Excluded:

  • Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002339
Other Study ID Numbers  ICMJE 120
R-0220
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP