New Therapies and Biomarkers for Chagas Infection

Summary

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.

Conditions

• Trypanosoma Cruzi Infection
• Chagas Disease

Interventions

DRUG

Benznidazole

50 mg and 100 mg tablet taken orally

DRUG

Nifurtimox

120 mg tablet taken orally

Sponsors & Collaborators

• Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES)

  collaborator UNKNOWN

• Barcelona Institute for Global Health

  collaborator OTHER

• Institute of Parasitology and Biomedicine Lopez Neyra

  collaborator UNKNOWN

• U.S. Food and Drug Administration (FDA)

  collaborator UNKNOWN

• Drugs for Neglected Diseases

  collaborator OTHER

• Mundo Sano Foundation

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Texas, El Paso

  lead OTHER

Principal Investigators

• Igor C Almeida, D.Sc. · The University of Texas at El Paso (UTEP)

• Faustino Torrico, M.D., Ph.D · Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES)

• Joaquim Gascon, M.D., Ph.D · Barcelona Institute for Global Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-18

Primary Completion

2024-05-29

Completion

2024-05-31

FDA Drug

Yes

Countries

• Bolivia

Study Locations