A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS

Inclusion Criteria Concurrent Medication: Allowed: * Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma. * Erythropoietin. * Didanosine by exemption for 10 patients. * Barbiturates. * Coumarin-type anticoagulants. * Oral contraceptives. * Digoxin. * Methadone. * Narcotics. * Acyclovir. * Acetaminophen. * Sulfonamides. * Trimethoprim / sulfamethoxazole. * Pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis. * Topical antifungals. * Pyrimethamine. * Ganciclovir. * AZT. * Stress doses of steroids in patients with adrenal insufficiency. Concurrent Treatment: Allowed: * Dose reduction or interruption of myelosuppressive therapy and transfusion to maintain hemoglobin of 7 or more g/dl. * Radiation therapy. Patient must: * Show laboratory evidence of HIV infection and disseminated histoplasmosis. * Be oriented to person, place, and time. * Be able to give written informed consent (appropriate consent must be obtained from a parent or legal guardian for patients under 18 years of age). Allowed: * Abnormal liver function tests in Grade 3 toxicity range if liver biopsy shows evidence that histoplasmosis caused these abnormalities. * Mucocutaneous candidiasis. Prior Medication: Allowed: * Amphotericin B or ketoconazole for pulmonary histoplasmosis at least 3 months prior to study entry. * Azidothymidine (AZT). * Vincristine, vinblastine, bleomycin, or interferon for mucocutaneous Kaposi's sarcoma. * Prophylaxis for Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Severely ill, or at risk of dying from histoplasmosis within the first week of treatment, as indicated by systolic blood pressure less than 90 mm Hg , or PO2 less than 60. * Active CNS lesions, malignancies, or infections other than MAI. * Severe malabsorption syndrome (persistent diarrhea more than 4 weeks duration with at least 4 loose stools per day accompanied by a 10 percent or greater weight loss). * Requiring cytotoxic therapy for malignancies. * Any systemic fungal infection other than histoplasmosis. * Systemic Mycobacterium avium intracellulare. * Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized. * History of allergy to or intolerance of imidazoles or azoles. Concurrent Medication: Excluded: * All other systemic antifungal agents. * Investigational drugs not specifically allowed. * Oral hypoglycemics. * Rifamycins. * Phenytoin. * Carbamazepine. * Steroids in excess of physiologic replacement doses not specifically allowed. * Cytotoxic chemotherapy. * Discouraged: * Antacids. * Sucralfate. * H2 blockers. Patients with the following are excluded: * Severely ill, or at risk of dying from histoplasmosis within the first week of treatment. * Active CNS infections, malignancies or lesions not documented to be caused by histoplasmosis, which would interfere with assessment of response. * Unable to take oral medications reliably. * Severe malabsorption syndrome. * Requiring cytotoxic therapy for malignancies. * Any systemic fungal infection other than histoplasmosis. * Systemic Mycobacterium avium intracellulare. * Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized. Prior Medication: Excluded for greater than 1 week within the last 3 months: * Fluconazole. * Itraconazole. * SCH 39304. * Amphotericin B greater than 1.5 mg/kg, or any other antifungal for this episode of disseminated histoplasmosis. Patients who the investigator feels would be undependable with regard to adherence to the protocol.