Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Detailed Description

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Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

Conditions

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Candidiasis, Oral HIV Infections

Keywords

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AIDS-Related Opportunistic Infections Dose-Response Relationship, Drug Fluconazole Antifungal Agents Candidiasis, Oral Pharyngeal Diseases MK 0991

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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L-743,872

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

You may be eligible for this study if you:

* Have thrush that has not responded to fluconazole treatment.
* Are 18-65 years old.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Carol Sable

Rahway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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012-00

Identifier Type: -

Identifier Source: secondary_id

267B