Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combination, Artemether/Lumefantrine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Pharmacokinetic assessment of potential drug-drug interactions of antimalarials and antiretroviral agents.
研究概览
简要总结
The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood.
The study medicines that will be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn about whether or not the use of these medicines together results in a change in blood levels of any of these medicines. The information obtained from this study will help doctors to provide a better treatment to children and adults with malaria and HIV.
详细描述
The study involves 5 non-consecutive overnight stays and 14 additional outpatient visits at the San Francisco General Hospital Research Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of HIV infection prior to study entry
- •Within 20% (+/-) of ideal body weight and must weigh at least 50kg
- •Healthy subjects without evidence of acute or chronic illnesses, including diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney impairment
排除标准
- •Use of illicit drugs or alcohol that could interfere with the completion of the study.
- •Use of any over- the- counter or prescribed drugs unless approved by the principal investigator or study physician.
- •Pregnant or breast- feeding.
- •History of acute or chronic illnesses, such as diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney impairment.
- •Evidence of acute illness.
- •Family history of congenital prolongation of QTc interval or with any conditions known to prolong QTc interval, such as cardiac arrhythmias, bradycardia or severe heart disease
- •History of electrolyte abnormalities.
研究组 & 干预措施
Lopinavir/ritonavir, artemethr/lumefantrine
Determination of the antimalarial drug levels artemether/lumefantrine in the absence and in the presence of co-administered antiretrovirals lopinavir and ritonavir.
干预措施: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine (Drug)
efavirenz, artemether, lumefantrine
Determination of the antimalarial drug levels artemether/lumefantrine in the absence and in the presence of co-administered antiretroviral efavirenz.
干预措施: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine (Drug)
结局指标
主要结局
Pharmacokinetic assessment of potential drug-drug interactions of antimalarials and antiretroviral agents.
时间窗: Intensive serial PK sampling of antimalarials conducted on study day 4 (without antiretrovirals) and study day 31 (in the context of antiretrovirals
次要结局
未报告次要终点
研究者
Fran Aweeka
Prinicpal Investigator
University of California, San Francisco