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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Candidiasis, Esophageal HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Fluconazole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

Houston Veterans Administration Med Ctr

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 7957784 (View on PubMed)

Other Identifiers

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R-0220

Identifier Type: -

Identifier Source: secondary_id

120