NCT04031053 (ITRAPK) is a clinical trial of Pharmacokinetic study in Pharmacokinetics, sponsored by Chiang Mai University.

Who is sponsoring NCT04031053?

NCT04031053 is sponsored by Chiang Mai University.

What drugs are being tested in NCT04031053?

Interventions in NCT04031053: Pharmacokinetic study.

What condition does NCT04031053 study?

NCT04031053 studies Pharmacokinetics, Efavirenz, Penicilliosis.

Is NCT04031053 still recruiting?

NCT04031053 is currently status unknown. Last updated 24 July 2019.

Last reviewed 2019-07-24 · How we verify

NCT04031053: ITRAPK

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Last updated 24 July 2019

What this trial tests

trial testing Pharmacokinetic study in Pharmacokinetics in 20 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Chiang Mai University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	20
Start date	1 June 2019
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across Thailand

Drugs / interventions tested

Pharmacokinetic study

Conditions studied

Pharmacokinetics — all drugs for Pharmacokinetics →
Efavirenz — all drugs for Efavirenz →
Penicilliosis — all drugs for Penicilliosis →

Sponsor

Chiang Mai University

Who can join

18 and older, any sex, with Pharmacokinetics or Efavirenz. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04031053 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chiang Mai University
Last refreshed: 24 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04031053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing