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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005921
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
Candidiasis, Esophageal HIV Infections Drug: L-743,872 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

You may be eligible for this study if you:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005921

United States, New Jersey
Gary Calandra
Rahway, New Jersey, United States, 07065
Sponsors and Collaborators
Merck Sharp & Dohme Corp. Identifier: NCT00005921     History of Changes
Other Study ID Numbers: 267A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
Antifungal Agents
Esophageal Diseases
MK 0991

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antifungal Agents
Anti-Infective Agents