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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Fluconazole

About this trial

This is an interventional treatment trial for Candidiasis, Esophageal focused on measuring Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Immunocompromised Host

Eligibility Criteria

13 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Los Angeles County - USC Med Ctr
Houston Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002339

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00002339

Brief Title

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

Official Title

An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 1996

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Candidiasis, Esophageal, HIV Infections

Keywords

Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Immunocompromised Host

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fluconazole

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

Los Angeles County - USC Med Ctr

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Houston Veterans Administration Med Ctr

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7957784

Citation

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. doi: 10.1007/BF01717446.

Results Reference

background

Candidiasis, Esophageal, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial