NCT02383849已完成不适用
IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
International Maternal Pediatric Adolescent AIDS Clinical Trials Group2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2015年8月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Clearance of NVP, INH, RIF, and LPV/r after oral dose
研究概览
简要总结
P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r). The study is designed to describe the pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the drug(s) as part of clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Days 至 84 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for Arms 1 and 3 (HIV-exposed infants):
- •Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP
- •Age 7 to 14 days
- •Birth weight less than 2500 grams
- •Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3)
- •Parent or legal guardian able and willing to provide written informed consent. [Note to sites: modify per locally relevant language].
- •Inclusion Criteria for Arm 2 (HIV-exposed infants):
- •Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP
- •Age 7 to 84 days
- •Birth weight less than or equal to 4000 grams
- •Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3)
- •Parent or legal guardian able and willing to provide written informed consent. [Note to sites: modify per locally relevant language].
- •Inclusion Criteria for Arm 4 (HIV-unexposed but TB exposed infants):
- •Age 7 to 84 days
- •Birth weight less than or equal to 4000 grams
- •Receiving prophylaxis with INH alone or INH plus RIF as prescribed by clinical care provider
- •Not receiving any therapy for HIV prophylaxis or treatment
- •Parent or legal guardian able and willing to provide written informed consent. [Note to sites: modify per locally relevant language].
- •Inclusion Criteria for Arms 5 and 6 (HIV-infected infants):
- •Documentation of HIV-1 infection defined as positive HIV DNA PCR done as part of clinical care. An HIV RNA confirmatory test must be done at study entry but results may be pending at time of enrollment.
- •Birth weight less than or equal to 4000 grams
- •Age less than or equal to 12 weeks (defined as 84 days)
- •Intention by clinical care provider to prescribe LPV/r plus 2 NRTIs and no RIF (Arm 5) or LPV/r plus 2 NRTIs plus RIF (Arm 6)
- •Parent or legally acceptable representative able and willing to provide written informed consent. [Note to sites: modify per locally relevant language].
排除标准
- •Any severe congenital malformation or other medical condition incompatible with life or that would interfere with study participation or interpretation, as judged by the examining clinician.
结局指标
主要结局
Clearance of NVP, INH, RIF, and LPV/r after oral dose
时间窗: Week 24 of life
Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r
次要结局
- Primary safety endpoints(Study duration)
研究者
研究点 (2)
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