PharmacokineticsITRAPKNCT04031053
Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
An observational study of Pharmacokinetics and Efavirenz, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Efavirenz, Penicilliosis
- What is being tested?
- Pharmacokinetic study
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2019to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected participant who has an evidence of T. marneffei invasive infection will be enrolled to the study.
Who may be able to join
- 18 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
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
- Being tested
- Pharmacokinetic study
- Keywords
- Pharmacokinetics, Efavirenz, Penicilliosis
- Medical subject headings
- talaromycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic studyOther
The blood will be collected at pre-dose and at 1, 3, 4, 5, 6, 8 and 12-hour post dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pharmacokinetic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itraconazole and its metabolites level
Itraconazole and its metabolite level will be measured to create drug level curve (before and after exposed to efavirenz)
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jun 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Responsible party
- Principal investigator, Quanhathai Kaewpoowat, Chiang Mai University
- Investigators
- Quanhathai Kaewpoowat, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031053
- Sponsor's protocol ID
- ITRAPK
- Acronym
- ITRAPK
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
- ClinicalTrials.gov ID
- NCT04031053
- Acronym / sponsor ID
- ITRAPK / ITRAPK
- Conditions
- Pharmacokinetics, Efavirenz, Penicilliosis
- Keywords
- Pharmacokinetics, Efavirenz, Penicilliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Pharmacokinetic Group | – | Other: Pharmacokinetic studyAfter 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. |
| Trough Level Group | – | Other: Pharmacokinetic studyOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected participant who has an evidence of T. marneffei invasive infection will be enrolled to the study.
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic studyThe blood will be collected at pre-dose and at 1, 3, 4, 5, 6, 8 and 12-hour post dose | Other | Intensive Pharmacokinetic Group, Trough Level Group |
Primary outcome
Itraconazole and its metabolites level
Time frame: 45 days
Itraconazole and its metabolite level will be measured to create drug level curve (before and after exposed to efavirenz)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quanhathai Kaewpoowat, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Efavirenz, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itraconazole and its metabolites level (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.