To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.

Condition	Treatment or Intervention
Candidiasis, Oral HIV Infections	Drug: Clotrimazole  Drug: Fluconazole

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Cimetidine.

Exclusion Criteria

Co-existing Condition: Patients with the following are excluded:

• Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
• Moderate or severe liver disease defined by specified lab values.

Concurrent Medication: Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:

• Barbiturates.
• Phenytoin.
• Coumarin-type anticoagulants.
• Rifampin.
• Oral hypoglycemics.
• Cyclosporin.

Patients with the following are excluded:

• Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
• Unable to tolerate oral medication.
• Moderate or severe liver disease defined by specified lab values.
• Life expectancy < 4 weeks.
• Unable or unwilling to be followed at the same center for the conduct of this study.

Prior Medication: Excluded within 3 days of study entry:

• Other antifungal agents.
• Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
• Barbiturates.
• Phenytoin.
• Coumarin-type anticoagulants.
• Rifampin.
• Oral hypoglycemics.
• Cyclosporin.

Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).

• Patients who have given informed consent in writing to their participation in the study.
• Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.

California
      Davies Med Ctr, San Francisco,  California,  94114,  United States
      Summitt Med Ctr / San Francisco Gen Hosp, Oakland,  California,  94609,  United States
      Dr Robert Larsen, Los Angeles,  California,  90033,  United States
      UCSF Hosp, San Francisco,  California,  941430654,  United States
Connecticut
      Saint Raphael's Hosp, New Haven,  Connecticut,  06511,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21205,  United States
Massachusetts
      Univ Hosp, Boston,  Massachusetts,  02118,  United States
Missouri
      Washington Univ School of Medicine, St. Louis,  Missouri,  63108,  United States
New Jersey
      Saint Michael's Med Ctr, Newark,  New Jersey,  07102,  United States
New York
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States
      Cabrini Med Ctr, New York,  New York,  10003,  United States
      SUNY / Health Sciences Ctr at Stony Brook, Stony Brook,  New York,  117948153,  United States
Ohio
      Ohio State Univ Hosp, Columbus,  Ohio,  43210,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Univ TX San Antonio Health Science Ctr, San Antonio,  Texas,  78284,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States

Study ID Numbers:  012M; 056-171
Record last reviewed:  February 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002282
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08