Pharmacokinetic and Programmatic Evaluations to Optimize HIV/TB Co-Treatment Regimens in Children
优化儿童艾滋病毒/结核病联合治疗方案的药代动力学和规划评估
基本信息
- 批准号:10422433
- 负责人:
- 金额:$ 5.9万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-03 至 2022-01-31
- 项目状态:已结题
- 来源:
- 关键词:Acquired Immunodeficiency SyndromeAddressChildChildhoodCountryDataDrug KineticsEnrollmentEpidemicEvaluationFutureGoalsHIVHIV/TBHomeImprove AccessInternational Maternal Pediatric Adolescent AIDS Clinical TrialsKnowledgeLaboratoriesMonitorNigeriaOutcomePreventionPublic HealthRecommendationRegimenResearchResearch PriorityRifabutinRifampinSafetyTranslatingTreatment FailureTreatment ProtocolsTreatment outcomeTuberculosisWorld Health Organizationantiretroviral therapybasecare systemsclinical careco-infectionimprovedmortalitynoveloptimal treatmentspediatric human immunodeficiency viruspediatric patientsprogramsprospectivescreeningtreatment guidelinestreatment programtreatment strategytuberculosis treatment
项目摘要
PROJECT SUMMARY/ABSTRACT
The convergence of the global HIV and tuberculosis (TB) epidemics represents one of the most
urgent challenges facing global public health. Despite improved access to antiretroviral therapy (ART),
TB remains the leading killer of children with HIV. Furthermore, the task of treating children co-
infected with HIV and TB remains particularly challenging due to lack of optimal treatment regimens.
As a result, the World Health Organization (WHO) has designated the evaluation of newer treatment
options for children a research priority. To address this issue, we will combine programmatic and
pharmacokinetic (PK) analyses to critically evaluate both current and promising future treatment
regimens. We will assess current pediatric HIV/TB co-treatment options by examinig 10 years of
treatment data from over 5500 pediatric patients enrolled in the Harvard/AIDS Prevention Initiative in
Nigeria (APIN) program to identify predictors of HIV/TB treatment failure and/or mortality, with a
particular focus on ART timing and regimen selection. We will also evaluate the pharmacokinetics,
safety, and efficacy of two novel treatment strategies among co-infected children: (1) rifabutin-based
TB treatment in combination with LPV/r-based ART; and, (2) dolutegravir-based ART with concurrent
rifampin-based TB treatment, building upon emerging results from the IMPAACT P1093 study. This
combination of programmatic outcomes and PK analyses will provide critical data to advance the
treatment of pediatric HIV/TB co-infection.
The Harvard/APIN PEPFAR program has supported HIV care services for over 150,000 people in
Nigeria including over 5500 children since 2004. Children enrolled in this program receive free clinical
care, antiretroviral therapy, TB screening, and laboratory monitoring. This study will build upon this
well-established HIV treatment program to examine issues critical for efforts to improve pediatric
HIV/TB outcomes. Nigeria is home to more children living with HIV than any other country, with
60,0000 children newly infected with HIV in 2012 alone. By critically evaluating our current efforts and
performing PK studies to evaluate two novel co-treatment regimens, we will gain essential knowledge
that may translate into a change in treatment recommendations and begin to curb TB’s devastating
toll.
项目总结/摘要
全球艾滋病毒和结核病(TB)流行病的汇合是全球最严重的疾病之一。
全球公共卫生面临的紧迫挑战。尽管获得抗逆转录病毒疗法的机会有所改善,
结核病仍然是感染艾滋病毒儿童的主要杀手。此外,治疗儿童的任务-
由于缺乏最佳治疗方案,艾滋病毒和结核病感染者仍然特别具有挑战性。
因此,世界卫生组织(世卫组织)已指定评价较新的治疗方法,
儿童的选择是研究的优先事项。为了解决这个问题,我们将把联合收割机和
药代动力学(PK)分析,以批判性地评价当前和有希望的未来治疗
养生法我们将通过检查10年的情况来评估当前的儿科艾滋病毒/结核病联合治疗方案
年参加哈佛/艾滋病预防倡议的5500多名儿科患者的治疗数据,
尼日利亚(APIN)项目,以确定艾滋病毒/结核病治疗失败和/或死亡率的预测因素,
特别关注ART时机和方案选择。我们还将评估药代动力学,
两种新的治疗策略在合并感染儿童中的安全性和有效性:(1)以利福布丁为基础的
TB治疗联合基于LPV/r的ART;和(2)基于度鲁特韦的ART联合
基于IMPAACT P1093研究的新结果。这
方案成果和PK分析的结合将提供关键数据,
治疗儿童HIV/TB合并感染。
哈佛/APIN PEPFAR计划为15万多人提供了艾滋病毒护理服务,
尼日利亚,自2004年以来,包括5 500多名儿童。参加该计划的儿童将获得免费的临床
护理、抗逆转录病毒治疗、结核病筛查和实验室监测。本研究将以此为基础
一个完善的艾滋病毒治疗计划,以检查关键问题的努力,以改善儿科
艾滋病毒/结核病成果。尼日利亚是艾滋病毒感染儿童最多的国家,
仅2012年就有6万儿童新感染艾滋病毒。通过批判性地评估我们目前的努力,
进行PK研究以评价两种新型联合治疗方案,我们将获得必要的知识
这可能会转化为治疗建议的改变,并开始遏制结核病的破坏性
通行费
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Holly Elizabeth Rawizza其他文献
Holly Elizabeth Rawizza的其他文献
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{{ truncateString('Holly Elizabeth Rawizza', 18)}}的其他基金
Mind the gaps: Pharmacokinetic research to advance pediatric HIV/TB cotreatment and TB prevention
注意差距:推进儿科艾滋病毒/结核病联合治疗和结核病预防的药代动力学研究
- 批准号:
10390005 - 财政年份:2022
- 资助金额:
$ 5.9万 - 项目类别:
Mind the gaps: Pharmacokinetic research to advance pediatric HIV/TB cotreatment and TB prevention
注意差距:推进儿科艾滋病毒/结核病联合治疗和结核病预防的药代动力学研究
- 批准号:
10605218 - 财政年份:2022
- 资助金额:
$ 5.9万 - 项目类别:
Acquired HIV drug resistance among Nigerian children failing first-line ART: Implications for second-line dolutegravir use
一线抗逆转录病毒疗法失败的尼日利亚儿童获得了艾滋病毒耐药性:对二线多替拉韦使用的影响
- 批准号:
10483175 - 财政年份:2021
- 资助金额:
$ 5.9万 - 项目类别:
Acquired HIV drug resistance among Nigerian children failing first-line ART: Implications for second-line dolutegravir use
一线抗逆转录病毒疗法失败的尼日利亚儿童获得了艾滋病毒耐药性:对二线多替拉韦使用的影响
- 批准号:
10326999 - 财政年份:2021
- 资助金额:
$ 5.9万 - 项目类别:
Rifabutin pharmacokinetics and safety among HIV/TB coinfected infants receiving lopinavir
接受洛匹那韦治疗的 HIV/TB 合并感染婴儿中利福布汀的药代动力学和安全性
- 批准号:
9926695 - 财政年份:2020
- 资助金额:
$ 5.9万 - 项目类别:
Pharmacokinetic and Programmatic Evaluations to Optimize HIV/TB Co-Treatment Regimens in Children
优化儿童艾滋病毒/结核病联合治疗方案的药代动力学和规划评估
- 批准号:
9140789 - 财政年份:2016
- 资助金额:
$ 5.9万 - 项目类别:
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