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

Chagas Disease Clinical Trial

— STOP CHAGAS  

Official title:

Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377480
• Other study ID #: P05267
• Secondary ID: MK-5592-055
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2011
• Est. completion date: January 12, 2015

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 12, 2015
• Est. primary completion date: July 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Drug:
• Posaconazole
POS 40 mg/mL oral suspension
• Placebo for posaconazole
Placebo oral suspension
• Benznidazole
BNZ 100 mg oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 Invest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction	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.	Day 180