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

Completed · Phase 2

Conditions studied: HIV Infections, Histoplasmosis

In brief

To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.

Key facts

Study ID

NCT00000975

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Expected to finish

1994-09-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• USC CRS — Los Angeles, California, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU — New Orleans, Louisiana, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Washington U CRS — St Louis, Missouri, United States
• Cornell University A2201 — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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