A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) (STOP CHAGAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01377480
First received: May 13, 2011
Last updated: July 13, 2015
Last verified: July 2015
  Purpose

This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.


Condition Intervention Phase
Chagas Disease
Drug: Posaconazole
Drug: Placebo for posaconazole
Drug: Benznidazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.


Enrollment: 120
Study Start Date: July 2011
Study Completion Date: January 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole
Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days
Drug: Posaconazole
POS 40 mg/mL oral suspension
Other Name: SCH 056592, MK-5592
Placebo Comparator: Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days
Drug: Placebo for posaconazole
Placebo oral suspension
Experimental: Posaconazole + Benznidazole
Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Drug: Posaconazole
POS 40 mg/mL oral suspension
Other Name: SCH 056592, MK-5592
Drug: Benznidazole
BNZ 100 mg oral tablet
Active Comparator: Benznidazole + Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Drug: Placebo for posaconazole
Placebo oral suspension
Drug: Benznidazole
BNZ 100 mg oral tablet

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)

  • Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
  • Must have a normal 12-lead electrocardiogram (ECG)
  • Must have a normal 2-D echocardiogram
  • Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
  • Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
  • Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug

Exclusion Criteria:

  • Are breastfeeding, pregnant, or planning to become pregnant
  • Body weight <60 kg
  • Have an immunodeficiency or are immunosuppressed
  • History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
  • Have previously received treatment with benznidazole or nifurtimox
  • Known allergy/sensitivity to azoles
  • Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
  • Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening
  • Has a history of severe alcohol abuse within two years from Screening
  • Is taking any of the prohibited medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377480

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01377480     History of Changes
Other Study ID Numbers: P05267, MK-5592-055
Study First Received: May 13, 2011
Results First Received: July 13, 2015
Last Updated: July 13, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Trypanosomiasis
Benzonidazole
Posaconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on September 02, 2015