Cookies disclaimer

I agree Our site saves small pieces of text information (cookies) on your device in order to deliver better content and for statistical purposes. You can disable the usage of cookies by changing the settings of your browser. By browsing our website without changing the browser settings you grant us permission to store that information on your device.

A Randomised, Open-Label, Comparative Study of Itraconazole vs Amphotericin B for the Induction Therapy of Penicilliosis. (360G-Wellcome-096471_Z_11_Z)

Penicilliosis is emerging as one of the three most common HIV-associated opportunistic infections in Asia.Despite the rapid growing HIV epidemics in a region that houses one half of the worlds population, there hasnot been a single randomised controlled trial to evaluate the treatment of penicilliosis. The currentrecommendation of amphotericin B for 2 weeks followed by itraconazole for 10 weeks is based on onenon-comparative study [1]. Amphotericin B has extremely limited availability, has significant side effects,needs to adminstered through a vein daily over 6 hours of infusion, and is prohibitively expensive in mostareas of Asia. Itraconazole, on the other hand, is widely available in local pharmacies throughout Asia, canbe given orally at a fraction of the price. Further, data from available case series suggest that itraconazoleand amphotericin B have similar efficacies. We therefore propose to conduct a randomised, open-label,non-inferiority trial of the efficacy of itraconazole versus amphotericin B for penicilliosis. 440 adults from inand outpatient settings with culture-confirmed penicilliosis will be recruited, randomly allocated to eitheritraconazole or amphotericin B treatment, monitored daily in-hospital for 2 weeks, and at monthly intervalsfor a total of 6 months. Primary outcome is mortality at 2 weeks. Secondary outcomes include 6-monthsurvival, clinical response, relapse, drug tolerability, and economic costs. Correlates of interests includeadmission prognostic factors, time-to-culture-sterilization, fungicidal activities, pharmacokinetic parameters,and serologic titres. These results will be available within five years and will either change or support currenttreatment guidelines for penicilliosis.


16 May 2011

Grant details
Amount Awarded 305683
Applicant Surname Le
Approval Committee Joint Global Health Trials Committee
Award Date 2011-05-16T00:00:00+00:00
Financial Year 2010/11
Grant Programme: Title Global Health Trials Award
Internal ID 096471/Z/11/Z
Lead Applicant Dr Thuy Le
Planned Dates: End Date 2016-01-31T00:00:00+00:00
Planned Dates: Start Date 2011-08-01T00:00:00+00:00
Recipient Org: Country United Kingdom
Region South East
Additional data added by GrantNav