Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

This study has been terminated.

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:	NCT00005920

Purpose

The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Condition	Intervention	Phase
Candidiasis, Oral HIV Infections	Drug: L-743,872	Phase II

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety Study
Official Title:	A Multiclinic, Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety, Tolerability, and Efficacy of L-743,872 in the Treatment of Fluconazole-Unresponsive Oropharyngeal Candidiasis in Adults

Resource links provided by NLM:

MedlinePlus related topics: AIDS Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

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

Estimated Enrollment:

Detailed Description:

Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

Eligibility

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Have thrush that has not responded to fluconazole treatment.
Are 18-65 years old.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005920

Locations

United States, New Jersey
Carol Sable
Rahway, New Jersey, United States, 07065

Sponsors and Collaborators

Merck

More Information

No publications provided

Study ID Numbers:	267B, 012-00
Study First Received:	June 19, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005920 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Dose-Response Relationship, Drug
Fluconazole
Antifungal Agents

Candidiasis, Oral
Pharyngeal Diseases
MK 0991

Additional relevant MeSH terms:

Fluconazole
Mouth Diseases
Anti-Infective Agents
Communicable Diseases
Candidiasis, Oral
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Candidiasis
Caspofungin
Acquired Immunodeficiency Syndrome

Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Therapeutic Uses
Antifungal Agents
Sexually Transmitted Diseases
Lentivirus Infections
Stomatognathic Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009