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

Tracking Information
First Submitted Date ICMJE	May 13, 2011
First Posted Date ICMJE	June 21, 2011
Results First Submitted Date	July 13, 2015
Results First Posted Date	August 10, 2015
Last Update Posted Date	May 18, 2017
Actual Study Start Date ICMJE	July 6, 2011
Actual Primary Completion Date	July 22, 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 13, 2015)	Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction [ Time Frame: Day 180 ]; 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.
Original Primary Outcome Measures ICMJE; (submitted: June 20, 2011)	Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ]
Change History	Complete list of historical versions of study NCT01377480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Official Title ICMJE	Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Chagas Disease
Intervention ICMJE	Drug: Posaconazole POS 40 mg/mL oral suspension Other Name: SCH 056592, MK-5592; Drug: Placebo for posaconazole Placebo oral suspension; Drug: Benznidazole BNZ 100 mg oral tablet
Study Arms	Experimental: Posaconazole Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days Intervention: Drug: Posaconazole; Placebo Comparator: Placebo Posaconazole placebo (10 mL) oral suspension twice daily for 60 days Intervention: Drug: Placebo for posaconazole; 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 Interventions: Drug: Posaconazole Drug: Benznidazole; 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 Interventions: Drug: Placebo for posaconazole Drug: Benznidazole
Publications *	Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 28, 2015)	120
Original Estimated Enrollment ICMJE; (submitted: June 20, 2011)	160
Actual Study Completion Date	January 12, 2015
Actual Primary Completion Date	July 22, 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Argentina, Chile, Colombia, Germany, Guatemala, Mexico, Spain
Administrative Information
NCT Number ICMJE	NCT01377480
Other Study ID Numbers ICMJE	P05267; MK-5592-055 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP