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

NCT04031053 | Unknown

• 1 other identifier: ITRAPK
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics; Efavirenz; Penicilliosis

Keywords

Pharmacokinetics; Efavirenz; Penicilliosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intensive Pharmacokinetic Group

After receiving the first dose of ITZ, a single blood sample will be collected 12-hours post-dose. On Day 7, the blood will be collected for intensive PK study. After 7 days of combined ITZ + EFV, a blood sample will be collected immediately (e.g. within 30 minutes) prior to administering the next ITZ dose. An identical set of intensive PK blood samples will be drawn 2 weeks after initiating the EFV based regimen.

Other: Pharmacokinetic study

Trough Level Group

On Days 7 and 14, a single blood sample will be collected immediately (e.g. within 30 minutes) prior to administering the next ITZ dose. After initiating an EFV based regimen, a single blood sample will be collected immediately (e.g. within 30 minutes) prior to administering the next ITZ dose on Days 7 and 14.

Other: Pharmacokinetic study

Interventions

Pharmacokinetic study OTHER

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

Intensive Pharmacokinetic Group; Trough Level Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected participant who has an evidence of T. marneffei invasive infection will be enrolled to the study.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiang Mai University: lead
• Thailand Research Fund: collaborator

Study Sites (1)

Chiang Mai University Hospital

Chiang Mai, 50200, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The plasma is stored for drug level analysis

MeSH Terms

Conditions

talaromycosis

Study Officials

• Quanhathai Kaewpoowat, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: July 24, 2019
• Study Start: June 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 24, 2019

Record last verified: 2019-04

Locations

TH (1)