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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002446
Other study ID # 305A
Secondary ID C97-331I97-331
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005
Start date August 1998

Study information

Verified date February 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Posaconazole

Fluconazole


Locations

Country Name City State
Barbados Queen Elizabeth Hosp Respiratory Unit St Michael
United States East Bay AIDS Ctr Berkeley California
United States SUNY / Health Science Ctr at Brooklyn Brooklyn New York
United States UMDNJ - New Jersey Med School / Cooper Hosp Camden New Jersey
United States Med Univ of South Carolina Charleston South Carolina
United States TRIAD Health Practice Chicago Illinois
United States Amelia Ct Clinic Dallas Texas
United States Infectious Disease and AIDS Clinic Denver Colorado
United States Wayne State Univ / Harper Hosp Detroit Michigan
United States Community Hosp Indianapolis Indianapolis Indiana
United States Boulevard Comprehensive Care Ctr Jacksonville Florida
United States Jersey City Med Ctr Jersey City New Jersey
United States Miami Veterans Administration Med Ctr Miami Florida
United States Univ of Pennsylvania School of Dental Medicine Philadelphia Pennsylvania
United States Univ of Texas Health Sciences Ctr San Antonio Texas
United States Kaiser Foundation Hospital San Francisco California
United States ViRx Inc San Francisco California
United States Dupont Circle Physicians Group Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Schering-Plough

Countries where clinical trial is conducted

United States,  Barbados, 

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