A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis

NCT ID: NCT00005921

Last Updated: 2005-06-24

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

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.

Detailed Description

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In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.

Conditions

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Candidiasis, Esophageal HIV Infections

Keywords

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Dose-Response Relationship, Drug Antifungal Agents Candidiasis Esophageal Diseases MK 0991

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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:

* Are an 18- to 65-year-old man with candidal esophagitis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Locations

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Gary Calandra

Rahway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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007-00

Identifier Type: -

Identifier Source: secondary_id

267A

Identifier Type: -

Identifier Source: org_study_id