Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

NCT ID: NCT00002446

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

Detailed Description

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Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Conditions

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Candidiasis, Oral HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Posaconazole

Intervention Type DRUG

Fluconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have thrush (oropharyngeal candidiasis).
* Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
* Are able to take study medication and return for clinic visits during the study.
* Are expected to live for at least 2 months.

Exclusion Criteria

You will not be eligible for this study if you:

* Have received protease inhibitors for the first time within 30 days prior to study entry.
* Have received certain medications.
* Have certain other types of fungal infections.
* Have certain types of cancer.
* Have received SCH 56592 within 3 months prior to study entry.
* Are pregnant or breast-feeding.
* Cannot take medications by mouth.
* Are allergic to azole drugs.
* Have certain medical conditions.
* Have been in this study before.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

ViRx Inc

San Francisco, California, United States

Site Status

Kaiser Foundation Hospital

San Francisco, California, United States

Site Status

Infectious Disease and AIDS Clinic

Denver, Colorado, United States

Site Status

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Site Status

Boulevard Comprehensive Care Ctr

Jacksonville, Florida, United States

Site Status

Miami Veterans Administration Med Ctr

Miami, Florida, United States

Site Status

TRIAD Health Practice

Chicago, Illinois, United States

Site Status

Community Hosp Indianapolis

Indianapolis, Indiana, United States

Site Status

Wayne State Univ / Harper Hosp

Detroit, Michigan, United States

Site Status

UMDNJ - New Jersey Med School / Cooper Hosp

Camden, New Jersey, United States

Site Status

Jersey City Med Ctr

Jersey City, New Jersey, United States

Site Status

SUNY / Health Science Ctr at Brooklyn

Brooklyn, New York, United States

Site Status

Univ of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, United States

Site Status

Med Univ of South Carolina

Charleston, South Carolina, United States

Site Status

Amelia Ct Clinic

Dallas, Texas, United States

Site Status

Univ of Texas Health Sciences Ctr

San Antonio, Texas, United States

Site Status

Queen Elizabeth Hosp Respiratory Unit

Saint Michael, , Barbados

Site Status

Countries

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United States Barbados

Other Identifiers

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C97-331

Identifier Type: -

Identifier Source: secondary_id

I97-331

Identifier Type: -

Identifier Source: secondary_id

305A

Identifier Type: -

Identifier Source: org_study_id