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A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
This study has been completed.
First Received: June 19, 2000   Last Updated: 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: Treatment, Open Label, Pharmacokinetics Study
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:


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

Estimated Enrollment: 18
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

Study ID Numbers: 267A, 007-00
Study First Received: June 19, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005921     History of Changes
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:
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Candidiasis
Gastrointestinal Diseases
Caspofungin
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Esophagitis
Digestive System Diseases
HIV Infections
Therapeutic Uses
Antifungal Agents
Sexually Transmitted Diseases
Lentivirus Infections
Esophageal Diseases
Gastroenteritis
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009