Clinical trial NCT00002446: Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
Official title: Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Fluconazole
Administration, Oral
Antifungal Agents
Candidiasis, Oral
Pharyngeal Diseases
posaconazole
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

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