Duration

01/2019 -

Coordinator

Igor Almeida, UTEP; Faustino Torrico, CEADES; Joaquím Gascón, ISGlobal

Funded by

U.S. National Institutes of Health (NIH)

Current approved treatments for Chagas disease (benznidazol, BZN and nifurtimos, NFX) were developed in the 1970s. The efficacy of both treatments in Chagas patients varies according to the stage of the diseases, the drug doses, the age of the patient and the strain of Trypanosoma cruzi, the parasite that causes the disease.   

In patients with chronic disease, these drugs fail in around 20% of cases and have a high frequency of adverse events. Recent data suggests that the drugs could be used at lower frequencies while maintaining the anti-parasitic effect.

Objectives

 This project proposes to test new dose regimens for these two old drugs. It has two main objectives:

• Determine if the efficacy of BZN or NFX is maintained when reducing the dose or treatment duration (to 30 or 15 days) and/or whether the efficacy improves when increasing it from 60 to 90 days.
• Evaluate new potential biomarkers of response to treatment and parasite elimination. Two types of biomarkers will be assessed: those derived from the host (anti-parasite antibodies) and those derived from the parasite (proteins secreted by the parasite).   

The project also has a series of secondary objectives, including: measure the reduction in parasite burden during the treatment, evaluate the serological response, characterize the pharmacokinetics of both drugs, evaluate the parasite genotype in patients that do not respond to treatment.   

Clinical trial

 This will be an open, randomized, prospectiva, observational phase 2 clinical trial with 6 parallel groups: three will receive different regimens of BZN and three will receive different regimens of NFX. 

Parasite clearance will be determined by molecular methods before, during and at different time points after the treatment.  

The study will be performed in Bolivia, in three sites (Cochabamba, Tarija y Sucre) of the Platform for the Comprehensive Care of Adult Chagas Patients.

Participating Institutions:

CEADES, Bolivia; University of El Paso, Texas, US; ISGlobal, Spain; Institute of Parasitology and Biomedicine López Neyra, Granada, Spain; Federal Drug Administration (FDA), Bethesda, US.