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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04031053

Acronym

ITRAPK

Enrollment

Registered

2019-07-24

Start date

2019-06-01

Completion date

2021-04-30

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efavirenz, Penicilliosis, Pharmacokinetics

Keywords

Pharmacokinetics, Efavirenz, Penicilliosis

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. 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.

Interventions

OTHERPharmacokinetic study

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026