NCT00474435Unknown2 期
The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania
African Poverty Related Infection Oriented Research Initiative2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pharmacokinetic parameters of emtricitabine, tenofovir and efavirenz
研究概览
简要总结
In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.
详细描述
The primary objectives of this pilot study in 30 patients are:
- To determine the effect of rifampin-containing tuberculostatic treatment on the pharmacokinetic profile of emtricitabine+tenofovir+efavirenz, when co-formulated in one tablet, in HIV-infected patients with smear-positive pulmonary tuberculosis in Tanzania.
- To determine the effect of the emtricitabine+tenofovir+efavirenz regimen on the pharmacokinetics of tuberculostatics in the same population.
The secondary objectives are:
- To determine the safety of co-administration of emtricitabine+tenofovir+efavirenz with treatment for smear-positive pulmonary tuberculosis.
- To determine the short-term (24 weeks) virological efficacy on HIV of an emtricitabine+tenofovir+efavirenz regimen in patients with smear-positive pulmonary tuberculosis.
- To determine the short-term bacteriological efficacy on smear-positive tuberculosis of the co-administration of a standard regimen for tuberculosis and an emtricitabine+tenofovir+efavirenz regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A smear-positive pulmonary tuberculosis, based on positive smear of at least two sputum samples with Ziehl-Neelsen (ZN) staining.
- •HIV-infected as documented by positive HIV antibody test.
- •Subject is at least 18 years of age at the day of the first dosing of study medication.
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- •CD4 cell count > 50 copies/mm
- •Karnofsky score >
- •Willing and able to regularly attend the Kibung'oto National Tuberculosis Hospital (KNTH) clinic.
排除标准
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
- •Previously treated for HIV infection with antiretroviral agents.
- •Pregnant or breastfeeding.
- •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •A history of severe psychiatric disease such as psychosis, schizophrenia, etc.
- •Inability to understand the nature and extent of the trial and the procedures required.
- •Abnormal serum transaminases or creatinine, determined as levels being > 5 times upper limit of normal.
- •Active hepatobiliary or hepatic disease (Non B Chronic Hepatitis B/C co-infection is allowed).
- •CD4 cell count > 350 cells/mm3.
结局指标
主要结局
Pharmacokinetic parameters of emtricitabine, tenofovir and efavirenz
时间窗: Two 24 hour pharmacokinetic (PK) curves (week 8 and 28)
Pharmacokinetic parameters of the tuberculostatic agents
时间窗: Pharmacokinetic (PK) samples at 2 hours and 6 hours postdose (week 2 and 8)
次要结局
- Biochemistry and haematology samples for safety(Samples at screening, baseline, week 2, 4, 6, 8, 12, 16, 24, 28)
- Questioning about occurrence of adverse events(At baseline, week 2, 4, 6, 8, 12, 16, 24, 28)
- CD4 count and HIV-1 RNA(At screening, week 4, week 16 and week 28)
- Sputum staining and culture(At screening, week 4, 8, and 28)
研究者
研究点 (2)
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