To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Condition	Treatment or Intervention
Candidiasis, Oral HIV Infections	Drug: Itraconazole

Further Study Details: 

Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV antibody seropositivity or diagnosis of AIDS.
• Confirmed oropharyngeal candidiasis.
• Failed fluconazole treatment within the past 14 days.
• Life expectancy of at least 3 months.
• NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
• NO prior disseminated candidiasis.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Underlying clinical condition that precludes study completion or places the patient at significant risk.
• Considered unreliable about following physician's directives. Concurrent Medication: Excluded:
• Investigational drugs (approved expanded access drugs are permitted).
• Rifampin.
• Rifabutin.
• Phenobarbital.
• Phenytoin.
• Carbamazepine.
• Terfenadine.
• Astemizole. Patients with the following prior conditions are excluded:
• History of hypersensitivity to imidazole or azole compounds.
• Clinical evidence of significant hepatic disease within the past 2 months. Prior Medication: Excluded:
• Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
Arkansas
      Univ of Arkansas for Med Sciences, Little Rock,  Arkansas,  72205,  United States
California
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
      Veterans Administration Med Ctr, Washington,  District of Columbia,  20422,  United States
      Dr Douglas Ward, Washington,  District of Columbia,  20009,  United States
Indiana
      Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
Maryland
      Natl Inst of Allergy & Infect Dis / Cln Ctr, Bethesda,  Maryland,  20892,  United States
Michigan
      Wayne State Univ / Harper Hosp, Detroit,  Michigan,  48201,  United States
      Ann Arbor Veterans Administration Med Ctr, Ann Arbor,  Michigan,  48105,  United States
Missouri
      Washington Univ, St. Louis,  Missouri,  63108,  United States
Ohio
      Ohio State Univ Hosp, Columbus,  Ohio,  43210,  United States
Oklahoma
      Oklahoma City Veterans Administration Med Ctr, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Pennsylvania Hosp, Philadelphia,  Pennsylvania,  19107,  United States
Tennessee
      Infectious Disease Clinic, Nashville,  Tennessee,  37212,  United States
Texas
      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  United States
Virginia
      Univ of Virginia Health Sciences Ctr, Charlottesville,  Virginia,  22908,  United States

Study ID Numbers:  236B; ITR-USA-94
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002133
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08