A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS
Status:
Completed
Trial end date:
1994-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)