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

This study has been completed.

First Received on June 19, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005921

Purpose

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.

Condition	Intervention
Candidiasis, Esophageal HIV Infections	Drug: L-743,872

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Esophagus Disorders HIV/AIDS Yeast Infections

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this study if you:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005921

Locations

United States, New Jersey
Gary Calandra
Rahway, New Jersey, United States, 07065

Sponsors and Collaborators

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00005921 History of Changes
Other Study ID Numbers:	267A, 007-00
Study First Received:	June 19, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Esophageal Diseases
Esophagitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Mycoses
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Caspofungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012