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| Name | Class |
|---|---|
| Thailand Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic study | Other | The blood will be collected at pre-dose and at 1, 3, 4, 5, 6, 8 and 12-hour post dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected participant who has an evidence of T. marneffei invasive infection will be enrolled to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Quanhathai Kaewpoowat, MD | Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiang Mai University Hospital | Chiang Mai | 50200 | Thailand |
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The plasma is stored for drug level analysis
| ID | Term |
|---|---|
| C000656865 | talaromycosis |
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