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NCT00005921 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
An Open, Serial-Panel, Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of L-743,872 in Patients With Candida Esophagitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005921
Other study ID # 267A
Secondary ID 007-00
Status Completed
Phase N/A
First received June 19, 2000
Last updated June 23, 2005

Study information
Verified date June 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria

You may be eligible for this study if you:

- Are an 18- to 65-year-old man with candidal esophagitis.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• L-743,872

Locations
Country Name City State
United States Gary Calandra Rahway New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

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