PACTR202012605595028尚未招募4 期
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum
ational Institute of Allergy and Infectious Diseases0 个研究点目标入组 30 人开始时间: 2020年11月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- All
入选标准
- •Mother is of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures, and is willing and able to provide written informed consent for her own and her infant’s participation in this study.
- •Prior to study entry, HIV status confirmed as HIV infected
- •At study entry, pregnant and in one of the following two enrollment windows, based on best available obstetrical estimate of gestational age:
- •Second trimester: gestational age of 20 0/7 to 26 6/7 weeks
- •Third trimester: gestational age of 30 0/7 to 37 6/7 weeks
- •At study entry, receiving at least two of the following first-line TB treatment drugs under study AND at least one of the following ARV drugs or drug combinations under study, based on maternal report and available medical records:
- •First-line TB treatment drugs:
- •Isoniazid (INH) 4-6 mg/kg (max 300 mg) q.d.
- •Rifampin (RIF) 8-12 mg/kg (max 600 mg) q.d.
- •Rifabutin (RFB) 150-300 mg q.d.
- •Ethambutol (EMB) 15-20 mg/kg q.d.
- •Pyrazinamide (PZA) 20-30 mg/kg q.d.
- •Moxifloxacin (MFX) 400 mg or 800mg q.d.
- •Arm 3.1 Dolutegravir (DTG) 50 mg b.i.d. when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen
- •Arm 3.2 Atazanavir/ritonavir (ATV/r) =300/100 mg q.d. or Darunavir/ritonavir (DRV/r) = 600/100 mg b.i.d.
- •Arm 3.3 Lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d.
- •At study entry, has been receiving the drug combination under study at the required dose for at least two weeks based on maternal report and available medical records.
- •At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 – 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.
- •At study entry, if receiving a generic ARV or TB formulation of the drug or drug combination under study, approval of the formulation.
排除标准
- •At study entry, mother has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records.
- •At study entry, has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the ARV or TB drug under study during the period of study follow-up.
- •4.2.3 Arms 1.3, 1.4 and 1.5 only: At study entry, mother has received TDF-based therapy within the past 6 months.
研究者
相似试验
已完成
不适用
Pharmacokinetic Interaction between Antiretroviral and Cytotoxic therapy in HIV-infected patients - a pilot studyHuman Immunodeficiency Virus (HIV)1002531910047438lymphomaNL-OMON37346Onze Lieve Vrouwe Gasthuis10
终止
不适用
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and PostpartumTuberculosisHIV InfectionsHIVNCT04518228National Institute of Allergy and Infectious Diseases (NIAID)205
招募中
不适用
The interaction of Antiretroviral Drugs with the MicrobiomeCirculatory SystemHIV/AIDSNutritional, Metabolic, EndocrinePACTR202108587192356WS300
招募中
不适用
The pharmacokinetics of lopinavir/ritonavir, nevirapine and efavirenz when given with isoniazid in South African HIV-infected individualsHIV/AIDSTuberculosisPACTR201206000391313niversity of Cape Town70
已完成
不适用
Pharmacokinetics of selected antiinfectives during extracorporeal membrane oxygenation (ECMO)J96.0Acute respiratory failureDRKS00010765niversitätsklinikum Hamburg-EppendorfKlinik für Intensivmedizin44