A Study of the Side Effects of L-743,872 in Men With Cand... | NCT00005921

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

NCT00005921

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Candidiasis, Esophageal
HIV Infections

Interventions

L-743,872

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
007-00

Status Module

Record Verification Date

Jun 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 19, 2000

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
L-743,872	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Gary Calandra		Rahway	New Jersey	07065	United States

Condition Browse Module

MeSH Terms

ID	Term
D002177	Candidiasis
D015658	HIV Infections
D004935	Esophageal Diseases

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000086982	Blood-Borne Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077336	Caspofungin

Ancestor Terms

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided