Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Disseminated histoplasmosis (DH) is one of the major AIDS-defining infections responsible for
high mortality rates in HIV-infected patients. Liposomal amphotericin B (L-AmB) is considered
the therapy of choice for AIDS-associated histoplasmosis.However, many patients in Latin
America are still treated with high doses of deoxycholate amphotericin B (d-AmB) for long
periods. These regimens are associated with toxicity and thus reduced efficacy. Therefore, a
better treatment strategy is necessary to improve the activity of this amphotericin B
treatment. Treatment with a high dose of L-AmB for short periods (rather than standard doses
for longer periods) is a promising approach considering that the antifungal effect of
amphotericin B depends on peak concentrations. This randomized open-label Phase II study aims
to determinate and to compare the activity and safety of three L-AmB regimens, as induction
therapy for DH in AIDS patients.
Phase:
Phase 2
Details
Lead Sponsor:
Alessandro Pasqualotto
Collaborators:
Hospital de Clinicas de Porto Alegre Hospital Nossa Senhora da Conceicao Irmandade Santa Casa de Misericórdia de Porto Alegre