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



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

For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 300

Location and Contact Information:

Univ of Pennsylvania School of Dental Medicine
Philadelphia,  Pennsylvania,  19104
United States
 

Jersey City Med Ctr
Jersey City,  New Jersey,  07304
United States
 

ViRx Inc
San Francisco,  California,  94109
United States
 

Univ of Texas Health Sciences Ctr
San Antonio,  Texas,  78284
United States
 

Queen Elizabeth Hosp Respiratory Unit
St Michael,  , 
Barbados
 

Community Hosp Indianapolis
Indianapolis,  Indiana,  46219
United States
 

TRIAD Health Practice
Chicago,  Illinois,  60657
United States
 

Infectious Disease and AIDS Clinic
Denver,  Colorado,  80204
United States
 

UMDNJ - New Jersey Med School / Cooper Hosp
Camden,  New Jersey,  08103
United States
 

Miami Veterans Administration Med Ctr
Miami,  Florida,  33125
United States
 

Wayne State Univ / Harper Hosp
Detroit,  Michigan,  48201
United States
 

Amelia Ct Clinic
Dallas,  Texas,  75235
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  29425
United States
 

East Bay AIDS Ctr
Berkeley,  California,  94705
United States
 

Kaiser Foundation Hospital
San Francisco,  California,  94118
United States
 

SUNY / Health Science Ctr at Brooklyn
Brooklyn,  New York,  11203
United States
 

Dupont Circle Physicians Group
Washington D.C.,  District of Columbia,  200091104
United States
 

Boulevard Comprehensive Care Ctr
Jacksonville,  Florida,  32209
United States
 


Additional Information:
Study ID Numbers:
  305A;  C97-331,I97-331
Study Start Date: August 1998
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002446

Other Hiv Infections Studies:
1. Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

2. A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers

3. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

4. A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations

5. A Study of Trimetrexate Plus Leucovorin in Children with Pneumocystis Carinii Pneumonia

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