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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01377480
First received: May 13, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

This is a study to compare the efficacy of Oral Posaconazole (POS) to placebo for the treatment of asymptomatic 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: Single Blind (Subject)
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:
  • Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole Drug: Posaconazole
10 mL orally twice daily for 60 days
Other Name: SCH 056592
Placebo Comparator: Posaconazole Placebo Drug: Placebo for posaconazole
10 mL orally twice daily for 60 days
Experimental: Posaconazole + Benznidazole Drug: Posaconazole
10 mL orally twice daily for 60 days
Other Name: SCH 056592
Drug: Benznidazole
200 mg orally twice daily for 60 days
Active Comparator: Posaconazole Placebo+ Benznidazole Drug: Placebo for posaconazole
10 mL orally twice daily for 60 days
Drug: Benznidazole
200 mg orally twice daily for 60 days

  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01377480     History of Changes
Other Study ID Numbers: P05267
Study First Received: May 13, 2011
Last Updated: February 17, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Posaconazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on July 28, 2014