NCT02346487已完成3 期
Prospective Study of Lopinavir Based ART for HIV Infected childreN Globally
Drugs for Neglected Diseases10 个研究点 分布在 3 个国家目标入组 1,003 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,003
- 试验地点
- 10
- 主要终点
- Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response <1000 copies/ml ii) being alive and iii) on study drug
研究概览
简要总结
The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.
详细描述
The primary objective is to evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed dose combination (FDCs) tablet under routine treatment conditions in HIV infected infants and young children who cannot swallow tablets.
As secondary objectives:
- Document the safety of LPV/r pellets and AZT/3TC or ABC/3TC
- Assess the population pharmacokinetics of LPV/r and NRTIs when administered as LPV/r pellets plus AZT/3TC or ABC/3TC
- Measure adherence to the new formulation
- Evaluate children acceptability of the LPV/r pellets and associated dual NRTIs as well as ease of use by the care giver.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples taken at a different date as preferred option.
- •At any age: HIV-1 DNA PCR positivity
- •At any time >4 weeks of age: HIV-1 p24 antigen detection or HIV-1 RNA viral load > 5,000 copies/mL plasma
- •At any age >18 months: HIV-1 antibody reactive on two different manufacturers' licensed rapid tests based on a different antigen preparation and/or different test principal, or repeatedly reactive on a licensed enzyme immune assay (EIA)and confirmed on a second sample by any one of the following assays: rapid test (a third manufacturer), licensed EIA, Western blot, chemi-luminescence assay, or plasma RNA with a viral load > 5,000 copies/mL
- •One single positive PCR assay result will be acceptable for inclusion of a child less than 18 months in the study Although the 2nd PCR assay would not be performed at the time of treatment initiation/treatment switch,
- •In case the test is RNA PCR viral load), the sample should be taken before treatment initiation and analyzed as soon as possible thereafter,
- •In case the child is already on treatment, the test should be DNA PCR based, the blood sample can be taken while on treatment and the results be made available as soon as possible.
- •ARV treatment eligible children with LPV-based treatment indication* as defined by country-specific guidelines or the WHO pediatric treatment guidelines confirmed by investigator:
- •ARV naïve, or
- •Already on first line liquid lopinavir based treatment, or
- •Failing first line NNRTI based therapy
- •Weight ≥3 and <25 kg at the time of enrolment.
- •Inability to swallow tablets*
- •Parent or legal guardian able and willing to provide written informed consent. *Age is not an inclusion criterion. Children older than 5 years who need a LPV/r based treatment and cannot swallow tablets are eligible. Analysis will be stratified according to study entry point (naïve, first line, failure)
- •Exclusion criteria
- •Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or PIs other than LPV/r.
- •PIs treatment failure with the presence or strong suspicion of a PI resistance mutation.
- •Clinical condition requiring the use of a prohibited medication in association with LPV/r
- •Any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study.
排除标准
- 未提供
研究组 & 干预措施
LPV/RTV pellets and AZT/3TC or ABC/3TC
Experimental
Only 1 arm. No comparator
干预措施: LPV/RTV pellets and AZT/3TC or ABC/3TC (Drug)
结局指标
主要结局
Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response <1000 copies/ml ii) being alive and iii) on study drug
时间窗: 48 weeks
• Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response \<1000 copies/ml ii) being alive and iii) on study drug
次要结局
- Treatment effectiveness based on virologic, immunologic and clinical endpoints(96 weeks)
- Rate of AEs/SAEs as measure of safety(96 weeks)
- Pharmacokinetics - Plasma AUC(96 weeks)
- Feasibility and acceptability questionnaires(96 weeks)
- Pharmacokinetics - Tmax(96 weeks)
- Pharmacokinetics - C12/Cmin(96 weeks)
研究者
研究点 (10)
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