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

Sponsored by:	Schering-Plough
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002446

Purpose

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.

Condition	Intervention	Phase
Candidiasis, Oral HIV Infections	Drug: Posaconazole Drug: Fluconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
Official Title:	Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Yeast Infections

Drug Information available for: Fluconazole Posaconazole

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	300
Study Start Date:	August 1998

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002446

Locations

United States, California
ViRx Inc
San Francisco, California, United States, 94109
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
East Bay AIDS Ctr
Berkeley, California, United States, 94705
United States, Colorado
Infectious Disease and AIDS Clinic
Denver, Colorado, United States, 80204
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 200091104
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, United States, 32209
United States, Illinois
TRIAD Health Practice
Chicago, Illinois, United States, 60657
United States, Indiana
Community Hosp Indianapolis
Indianapolis, Indiana, United States, 46219
United States, Michigan
Wayne State Univ / Harper Hosp
Detroit, Michigan, United States, 48201
United States, New Jersey
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States, 08103
Jersey City Med Ctr
Jersey City, New Jersey, United States, 07304
United States, New York
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, United States, 11203
United States, Pennsylvania
Univ of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 78284
Amelia Ct Clinic
Dallas, Texas, United States, 75235
Barbados
Queen Elizabeth Hosp Respiratory Unit
St Michael, Barbados

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Study ID Numbers:	305A, C97-331, I97-331
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002446 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Fluconazole
Administration, Oral
Antifungal Agents

Candidiasis, Oral
Pharyngeal Diseases
posaconazole

Study placed in the following topic categories:

Fluconazole
Mouth Diseases
Anti-Infective Agents
Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Acquired Immunodeficiency Syndrome
Pharyngeal Diseases
Immunologic Deficiency Syndromes
Virus Diseases

Anti-Bacterial Agents
Mycoses
HIV Seropositivity
HIV Infections
Antifungal Agents
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Posaconazole
Retroviridae Infections

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Slow Virus Diseases
Candidiasis
Infection
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal

Posaconazole
Retroviridae Infections
Fluconazole
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 02, 2009