A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

Launched by JANSSEN, LP · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV infection.
• • Residence in an area endemic for H. capsulatum.
• • Absolute CD4 count \< 150 cells/mm3.
• • No current or past active histoplasmosis.
• • No other active fungal infection.
• • Life expectancy of at least 1 year.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
• • Inability to take oral medication.
• Concurrent Medication:
• Excluded:
• • Systemically-active antifungals.
• • Investigational drugs (expanded access drugs are acceptable).
• • Rifampin.
• • Rifabutin.
• • Terfenadine.
• • Astemizole.
• • Phenobarbital.
• • Phenytoin.
• • Carbamazepine.
• • H2 blockers.
• • Omeprazole.
• • Continual antacids.
• Patients with the following prior conditions are excluded:
• • History of intolerance to imidazole or azole compounds.
• Prior Medication:
• Excluded within 1 month prior to study entry:
• • Investigational drugs (expanded access drugs are acceptable).
• Excluded within 15 days prior to study entry:
• • Rifampin.
• • Rifabutin.
• • Terfenadine.
• • Astemizole.
• • Phenobarbital.
• • Phenytoin.
• • Carbamazepine.