Chagas disease drug development

Phase 2

• Conditions: Chronic Chagas disease; Infections and Infestations; Chagas disease

• Registration Number: ISRCTN26467068
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-01
• Last Update Posted: 28 November 2023
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Adult volunteers with chronic T. cruzi infection, a blood-stage parasite density of at least 2 parasite equivalents per mL, with or without end-organ involvement and:
1.1. Participant is willing and able to give informed consent for participation in the study.
1.2. Adult patients, male or female, aged over 18 years and less than 99 years.
1.3. Lives in the Belo Horizonte metropolitan area and can comply with study procedures.
1.4. Circulating parasitaemia greater or equal to 2 parasites equivalent per mL.

Exclusion Criteria

1. Has received prior treatment with benznidazole, nifurtimox or posaconazole (either completely or incompletely).
2. History of hypersensitivity, allergic, or serious adverse reactions to any nitroimidazole compound, posaconazole and/or its components.
3. Inability to attend follow-up visits on the stipulated dates.
4. Acute or chronic health problems that, in the opinion of the principal investigator, may interfere with study completion.
5. Alcohol or drug dependence.
6. HIV infection or is immunocompromised.
7. Pregnant or breastfeeding.
8. Patients taking any immunosuppressant drugs.
9. QT prolongation (>450 ms for males; >470 ms for females).
10. Basic laboratory parameters outside the normal range or that are considered clinically relevant by the physician responsible for the patient.
10.1. Total white blood cell counts outside the normal range, as defined by an acceptable margin of +/- 5% (3,800 - 10,500 / mm3);
10.2. Transaminases (ALT and AST) outside the normal range, as defined by 25% above the upper limit of normal (ULN, > 1.25 x ULN).
11. Therapy with drugs metabolized by CYP3A4, such as terfenadine, astemizole, pimozide, halofantrine or quinidine, and HMG-CoA reductase inhibitors (simvastatin, lovastatin, and atorvastatin).
12. Patients receiving treatment with proton pump inhibitors or H2 receptor antagonists, phenytoin, efavirenz, and rifabutin, or who cannot discontinue it during the study period.
13. Patients receiving any drugs known to prolong the QT interval significantly.

Study & Design

• Study Type: Interventional
• Study Design: Not specified