Chagas disease (CD) is an endemic zoonotic disease with a significant global impact. Current
approved treatments for CD (benznidazole (BZN) and nifurtimox (NFX)) were developed in the
1970s with regimens and dosing intervals derived from decades-old patient series and with
very limited direct comparisons. Treatment recommendations vary significantly from country to
country and the comparative evidence-base with the current treatment regimens is limited.
The reported efficacy of both drugs in patients with T. cruzi infection is variable and
depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi
strain or genotype. Due to a therapeutic failure of at least 20% after 12 months in chronic
patients and the high rate of adverse events, together with the recent data that suggest that
we may be overdosing patients, we propose to test new dosing regimens of these two old
compounds.
Hypotheses:
- Lowering the frequency of drug dosing of BZN and NFX, the plasma drug levels of the
drugs within the therapeutic range will be maintained.
- The duration of treatment with BZN or NFX may be related to the effectiveness of these
drugs.
- Blood levels of the proposed biomarkers will significantly diminish or became negative
after a relatively short interval after treatment.
Phase:
Phase 2
Details
Lead Sponsor:
University of Texas, El Paso
Collaborators:
Barcelona Institute for Global Health Drugs for Neglected Diseases Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES) Institute of Parasitology and Biomedicine Lopez Neyra Mundo Sano Foundation National Institute of Allergy and Infectious Diseases (NIAID) U.S. Food and Drug Administration (FDA)