Status:
UNKNOWN
Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
Lead Sponsor:
Chiang Mai University
Collaborating Sponsors:
Thailand Research Fund
Conditions:
Pharmacokinetics
Efavirenz
Eligibility:
All Genders
18+ years
Brief Summary
Talaromycosis continues to be a common opportunistic fungal infection among people living with HIV/AIDS (PLWHA) in Southeast Asia and remains a leading cause of death among this population. Itraconazo...
Eligibility Criteria
Inclusion
- 18 years or older
- Available documentation of HIV infection
- ITZ capsule therapy is indicated for talaromycosis infection with the anticipation to start on EFV-based ART
- Willing to consent and compliance to the study protocol
Exclusion
- History of ITZ allergy
- Pregnancy or lactation
- Use concurrent medication that could interfere with ITZ level
- Creatinine clearance less than 30 mL/min
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) value is more than 5 times of upper normal limit and total bilirubin is more than 3 times above upper normal limit
- Hemoglobin less than 7 mg/dL
- History of ITZ exposure within 35 days (only applicable to intense PK group)
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04031053
Start Date
June 1 2019
End Date
April 30 2021
Last Update
July 24 2019
Active Locations (1)
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1
Chiang Mai University Hospital
Chiang Mai, Thailand, 50200