Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults

Pharmacokinetics Clinical Trial

— ITRAPK  

Official title:

Assessment of Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04031053
• Other study ID #: ITRAPK
• Status: Enrolling by invitation
• Start date: June 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2019
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. Itraconazole (ITZ) is an important component of talaromycosis treatment. In Thailand, the capsule formulation of ITZ is primarily used to treat talaromycosis but it is known to have lower bioavailability than the more expensive solution formulation. Limited data on the drug exposure of ITZ with the capsule formulation are available in adults PLWHA in Thailand. Moreover, the effect of efavirenz (EFV), which has been recommended as the first line antiretroviral therapy in Thailand, to ITZ level is not well understood. Thus, our aim is to assess ITZ pharmacokinetics with and without EFV in adult PLWHA receiving talaromycosis treatment with the capsule formulation. An understanding of the relationship between ITZ drug exposure and its active metabolite (hydroxyl-itraconazole) and treatment response is also planned to help optimize therapy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years or older

2. Available documentation of HIV infection

3. ITZ capsule therapy is indicated for talaromycosis infection with the anticipation to start on EFV-based ART

4. Willing to consent and compliance to the study protocol

Exclusion Criteria:

1. History of ITZ allergy

2. Pregnancy or lactation

3. Use concurrent medication that could interfere with ITZ level

4. Creatinine clearance less than 30 mL/min

5. 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

6. Hemoglobin less than 7 mg/dL

7. History of ITZ exposure within 35 days (only applicable to intense PK group)

Related Conditions & MeSH terms

• Efavirenz
• Penicilliosis
• Pharmacokinetics

Intervention

Other:
• Pharmacokinetic study
The blood will be collected at pre-dose and at 1, 3, 4, 5, 6, 8 and 12-hour post dose

Locations

Country	Name	City	State
Thailand	Chiang Mai University Hospital	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
Chiang Mai University	Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Itraconazole and its metabolites level	Itraconazole and its metabolite level will be measured to create drug level curve (before and after exposed to efavirenz)	45 days