Objectives

Through the clinical trials, led by ICS-HUVH and in three locations, the main objectives are:

·         To evaluate the candidate drug toxicity and security.

·         To determine pharmacokinetics of the candidate drug over infected patients.

·         To determine the candidate drug efficacy.

·         To determine the adequate dose of the candidate drug.

·         To evaluate the tripanocidal efficacy of albaconazol, alone and combined with the candidate drug.

 

Description of work (possibly broken down into tasks), and role of participants

·         Task 1. Design of a “Proof of Concept” clinical trial with albaconazole.

·         Task 2. Design of a Phase 1 clinical trial.

·         Task 3. Design of phase 2 Clinical trial.

 

·         Task 4. Collection of samples and definition of efficacy criteria.