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

HIV Infections Clinical Trial

Official title:

Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

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
• 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

• Candidiasis
• Candidiasis, Oral
• HIV Infections

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,