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临床试验/NCT04031053
NCT04031053Unknown不适用

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

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Itraconazole and its metabolites level

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Itraconazole and its metabolites level

时间窗: 45 days

Itraconazole and its metabolite level will be measured to create drug level curve (before and after exposed to efavirenz)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Quanhathai Kaewpoowat

Principal Investigator

Chiang Mai University

研究点 (1)

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