Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis
Status:
Completed
Trial end date:
2000-08-01
Target enrollment:
Participant gender:
Summary
Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase
in immunocompromised persons in our population. Persons with prolonged neutropenia secondary
to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients
undergoing bone marrow transplantation, receiving prolonged corticosteroid or other
immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even
with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In
bone marrow transplantation patients and in those whose infection involves the brain, this
mortality is greater than 90%. Amphotericin B in its conventional form, is the current
standard treatment for this disease. Response to therapy with amphotericin B usually ranges
between 20-60% in most studies. The higher response rates are usually seen in those patients
who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other
adverse effects, alternatives to conventional amphotericin B have been sought. These
currently include liposomal forms of amphotericin B and itraconazole. Although these forms
show a decrease in adverse effects, the efficacy of these drugs has not been shown to be
equivalent to conventional amphotericin B.
Voriconazole is an investigational antifungal drug currently being brought to phase III
trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in
animal models and early human trials to be effective against aspergillosis. It has been shown
to be well-tolerated and is available in an intravenous and oral formulation.
This study will evaluate the efficacy, safety, and toleration of voriconazole compared to
conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis
in immunocompromised patients. Patients will be randomized to open-labelled therapy with
voriconazole or amphotericin B in a one-to-one ratio.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Amphotericin B Liposomal amphotericin B Voriconazole