MedTrace Logo

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

NCT04031053 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-07-24

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Efavirenz
  • Penicilliosis

Interventions

OTHER

Pharmacokinetic study

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

Sponsors & Collaborators

  • Thailand Research Fund

    collaborator OTHER

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Quanhathai Kaewpoowat, MD · Chiang Mai University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031053 on ClinicalTrials.gov