An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

J

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

HIV Infections
Candidiasis, Oral

Treatments

Drug: Itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002133
236B
ITR-USA-94

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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