妊娠期和产后抗逆转录病毒和抗结核药物的药代动力学特性
本研究的目的是评估妊娠期和产后服用的抗逆转录病毒 (ARV) 和抗结核 (TB) 药物的药代动力学 (PK) 特性。
研究概览
地位
终止
详细说明
本研究将评估妊娠期和产后服用的抗逆转录病毒 (ARV) 和抗结核 (TB) 药物的药代动力学 (PK) 特性。
IMPAACT 2026 是一项 IV 期观察性临床研究。 参与者未分配到正在研究的药物，但已经通过其临床护理提供者的处方接受了用于临床护理的药物。 根据他们通过临床护理接受的药物将他们纳入研究组，如果使用多种感兴趣的药物，则能够同时纳入多个组。 本研究不提供抗逆转录病毒药物或结核病治疗药物。 所有正在研究的药物均由非研究来源提供。 研究发起人将此观察性研究添加到现有的研究性新药 (IND) 编号中以供超说明书使用，以防参与者的临床护理提供者决定开出高于批准剂量的剂量，如果批准剂量的 PK 结果表明该药物曝光可能不充分。
这项研究由五个组成部分组成，这些组成部分又由特定于正在评估的每种药物或药物组合的武器组成：
- 第 1 部分（武器 1.1、1.2。 1.3. 1.4. 和 1.5)：接受口服抗逆转录病毒药物但未接受结核病药物治疗的感染艾滋病毒 (WLHIV) 的孕妇及其婴儿。
- 第 2 部分（第 2.1 组）：在怀孕期间接受长效/缓释抗逆转录病毒药物治疗的 WLHIV 和未感染 HIV 的孕妇及其婴儿。
- 第 3 部分（第 3.1、3.2 和 3.3 部分）：接受抗逆转录病毒药物和一线结核病治疗的怀孕 WLHIV 及其婴儿。
- 组成部分 4（第 4.1 组）：接受二线结核病治疗的 WLHIV 和未感染 HIV 的孕妇及其婴儿。
- 第 5 部分（武器 5.1、5.2。 和 5.3)：产后 WLHIV 母乳喂养同时接受口服抗逆转录病毒药物及其婴儿。
每个组都将独立开放，并将在每个组首次注册后的大约 36 个月内独立累积。
第 1 部分的参与者将在母亲分娩后长达 12 周和婴儿出生后长达 24 周内接受随访。 第 2 部分的参与者将在母亲和婴儿分娩后 5 周内接受随访。 第 3、4 和 5 部分的参与者将在母亲和婴儿分娩后 24 周内接受随访。
考察访问可能包括：
- 第 1 部分：孕中期 (2T)、孕晚期 (3T)、分娩和产后 6-12 周 (PP) 的母体临床和实验室评估以及 PK 取样。 婴儿出生时和出生后 5-9 天的临床评估和洗脱 PK 取样。
- 第 2 部分：产妇临床和实验室评估以及分娩时的 PK 取样。 婴儿出生时、5-9 天和出生后 12-16 天的临床评估和洗脱 PK 取样。 产后5-9天、12-16天、3-5周母婴母乳转移PK取样。
- 第 3 部分：孕中期 (2T)、孕晚期 (3T)、分娩和产后 2-8 周 (PP) 的母体临床和实验室评估以及 PK 取样。 婴儿出生时和出生后 5-9 天的临床评估和洗脱 PK 取样。 产后5-9天、2-8周、16-24周母婴母乳转移PK取样。
- 第 4 部分：孕中期 (2T)、孕晚期 (3T)、分娩和产后 2-8 周 (PP) 的母体临床和实验室评估以及 PK 取样。 婴儿出生时和出生后 5-9 天的临床评估和洗脱 PK 取样。 产后5-9天、2-8周、16-24周母婴母乳转移PK取样。
- 组成部分 5：分娩后 5-9 天、2-12 周和 16-24 周的母婴临床评估和母乳转移 PK 取样。
研究类型
观察性的
注册 (实际的)
205
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kampala、乌干达
- Baylor-Uganda CRS
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Cape Town、南非、7505
- Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
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Tygerberg Hills、南非、7505
- Famcru Crs
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Gauteng
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Johannesburg、Gauteng、南非、2001
- Wits RHI Shandukani Research
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Maharashtra
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Pune、Maharashtra、印度、411001
- Byramjee Jeejeebhoy Medical College (BJMC) CRS
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Rio de Janeiro、巴西、20221-903
- Hospital Federal dos Servidores do Estado NICHD CRS
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Rio de Janeiro、巴西、26030
- Hosp. Geral De Nova Igaucu Brazil NICHD CRS
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San Juan、波多黎各、00935
- IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
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Bangkoknoi
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Bangkok、Bangkoknoi、泰国、10700
- Siriraj Hospital, Mahidol University NICHD CRS
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California
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Los Angeles、California、美国、90033
- Usc La Nichd Crs
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Los Angeles、California、美国、90095-1752
- David Geffen School of Medicine at UCLA NICHD CRS
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San Diego、California、美国、92103
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
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Colorado
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Aurora、Colorado、美国、80045
- Univ. of Colorado Denver NICHD CRS
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Florida
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Fort Lauderdale、Florida、美国、33316
- South Florida CDTC Ft Lauderdale NICHD CRS
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Jacksonville、Florida、美国、32209
- University of Florida Jacksonville NICHD CRS
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Miami、Florida、美国、33136
- Pediatric Perinatal HIV NICHD CRS
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University School of Medicine NICHD CRS
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Cook County Hospital Chicago NICHD CRS
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Chicago、Illinois、美国、60614
- Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001)
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Univ. Baltimore NICHD CRS
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New York
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The Bronx、New York、美国、10457
- Bronx-Lebanon Hospital Center NICHD CRS
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The Bronx、New York、美国、10461
- Jacobi Med. Ctr. Bronx NICHD CRS
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Kericho、肯尼亚、20200
- Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
感染和未感染 HIV 的孕妇和产后妇女（WLHIV 和未感染 HIV 的妇女）正在接受正在研究的 ARV 和/或 TB 药物，以及她们的婴儿。
描述
纳入标准：
第 1 部分：接受口服抗逆转录病毒药物但未接受结核药物治疗的怀孕 WLHIV 及其婴儿
- 母亲已达到法定年龄或能够根据研究中心标准操作程序 (SOP) 并符合研究中心机构审查委员会 (IRB)/伦理委员会 (EC) 的政策和程序，提供独立的知情同意，并且愿意并能够提供她自己和她的婴儿参与这项研究的书面知情同意书。
- 在进入研究之前，根据研究方案确认 HIV 状态为 HIV 感染。
在研究开始时，怀孕并处于以下两个登记窗口之一，基于最佳可用的产科孕龄估计：
- 孕中期：胎龄为 20 0/7 至 26 6/7 周
- 妊娠晚期：胎龄为 30 0/7 至 37 6/7 周
在研究开始时，根据产妇报告和可用的医疗记录，接受至少一种以下口服抗逆转录病毒药物或药物组合：
- 1.1 组：比克替拉韦 (BIC) 50 mg q.d.
- 第 1.2 组：Doravirine (DOR) 100 mg q.d.
- 第 1.3 组：替诺福韦艾拉酚胺 (TAF) - 10 mg q.d. 用考比司他增强
- 第 1.4 组：TAF 25 mg q.d. 没有提升
- 第 1.5 组：TAF 25 mg q.d. 用考比司他或利托那韦增强
- 在研究开始时，根据产妇报告和可用的医疗记录，计划在分娩后至少 12 周内继续目前的 ARV 方案。
- 在研究开始时，根据产妇报告和可用的医疗记录，已经以所需剂量接受研究中的药物或药物组合至少两周。
- 在研究开始时，研究人员评估为在妊娠 20 0/7 - 26 6/7 周（妊娠中期）或妊娠 30 0/7 至 37 6/7 周（妊娠晚期）内完成初始 PK 取样没有确定的障碍并在注册后 14 天内。
- 在研究开始时，如果接受研究中的药物或药物组合的通用制剂，则根据研究方案批准制剂。
- 在研究开始时，根据产妇报告和可用的医疗记录，未接受任何结核病药物（用于预防或治疗）。
第 2 部分：怀孕期间接受长效/缓释抗逆转录病毒药物治疗的 WLHIV 和未感染 HIV 的孕妇及其婴儿
- 如果达到法定年龄或以其他方式能够根据研究中心 SOP 提供独立的知情同意并符合研究中心 IRB/EC 政策和程序：愿意并能够为她自己和她的婴儿参与本研究提供书面知情同意。
- 如果未达到法定年龄或无法根据现场 SOP 提供独立的知情同意并符合现场 IRB/EC 政策和程序：父母/监护人或母亲及其婴儿的其他合法授权代表愿意并能够提供书面母亲及其婴儿参与研究的知情同意书；此外，在适用的情况下，母亲愿意并能够为她自己和她的婴儿的学习参与提供书面同意。
- 在研究开始时，打算根据产妇报告在研究附属诊所或医院分娩。
- 在研究开始时，根据最佳可用产科胎龄估计，胎龄至少为 24 0/7 周，并且尚未分娩。
在研究开始时，根据现有的医疗记录，在当前怀孕期间至少接受了以下一项管理：
- 第 2.1 组：cabotegravir (CAB LA) 的长效注射制剂（任何剂量）
第 3 部分：接受抗逆转录病毒药物和一线结核病治疗的怀孕 WLHIV 及其婴儿
- 母亲已达到法定年龄或能够根据研究中心 SOP 提供独立的知情同意书并符合研究中心 IRB/EC 政策和程序，并且愿意并能够为她自己和她的婴儿参与本研究提供书面知情同意书。
- 在进入研究之前，根据研究方案确认 HIV 状态为 HIV 感染。
在研究开始时，怀孕并处于以下两个登记窗口之一，基于最佳可用的产科孕龄估计：
- 孕中期：胎龄为 20 0/7 至 26 6/7 周
- 妊娠晚期：胎龄为 30 0/7 至 37 6/7 周
在研究开始时，根据母体报告和可用的医疗记录，接受至少两种正在研究的以下一线结核病治疗药物和至少一种正在研究的以下抗逆转录病毒药物或药物组合：
- 一线结核病治疗药物：
- 异烟肼 (INH) 4-6 mg/kg（最大 300 mg）q.d.
- 利福平 (RIF) 8-12 mg/kg（最大 600 mg）q.d.
- 利福布汀 (RFB) 150-300 mg q.d.
- 乙胺丁醇 (EMB) 15-20 mg/kg q.d.
- 吡嗪酰胺 (PZA) 20-30 mg/kg q.d.
- 莫西沙星 (MFX) 400 mg 或 800 mg q.d
- 抗逆转录病毒药物：
- 第 3.1 组：多替拉韦 (DTG) 50 mg b.i.d. 当与 RIF 或 50 mg q.d. 联合使用时 如果 RIF 不是结核病治疗方案的一部分
- 第 3.2 组：阿扎那韦/利托那韦 (ATV/r) ≥300/100 mg q.d.或达芦那韦/利托那韦 (DRV/r) ≥ 600/100 mg b.i.d.
- 第 3.3 组：洛匹那韦/利托那韦 (LPV/r) 800/200 mg b.i.d.
- 在研究开始时，根据产妇报告和可用的医疗记录，已经接受了至少两周所需剂量的研究药物组合。
- 在研究开始时，研究人员评估为在妊娠 20 0/7 - 26 6/7 周（妊娠中期）或妊娠 30 0/7 至 37 6/7 周（妊娠晚期）内完成初始 PK 取样没有确定的障碍并在注册后 14 天内。
- 在研究开始时，如果接受正在研究的药物或药物组合的通用 ARV 或 TB 制剂，则根据研究方案批准制剂。
- 在研究开始时，根据产妇报告和可用的医疗记录，计划在分娩后至少 8 周内继续目前的 ARV 方案。
组成部分 4 纳入标准：接受二线结核病治疗的 WLHIV 和未感染 HIV 的孕妇及其婴儿
- 母亲已达到法定年龄或能够根据研究中心 SOP 提供独立的知情同意书并符合研究中心 IRB/EC 政策和程序，并且愿意并能够为她自己和她的婴儿参与本研究提供书面知情同意书。
- 在进入研究之前，根据研究方案，HIV 状态确认为感染 HIV 或未感染 HIV。
在研究开始时，怀孕并处于以下两个登记窗口之一，基于最佳可用的产科孕龄估计：
- 孕中期：胎龄为 20 0/7 至 26 6/7 周
- 妊娠晚期：胎龄为 30 0/7 至 37 6/7 周
在研究开始时，根据产妇报告和可用的医疗记录，接受至少一种正在研究的以下二线结核病治疗药物：
- 第 4.1 组：二线结核病治疗药物：
- 左氧氟沙星 (LFX) 750mg - 1000mg q.d.
- 氯法齐明 (CFZ) 100mg q.d.
- 利奈唑胺 (LZD) 300mg - 600mg q.d.
- 贝达喹啉 (BDQ) 200 毫克 t.i.w.
- 德拉马尼 (DLM) 100 毫克 b.i.d.
- 莫西沙星 (MFX) 400mg 或 800mg q.d 和至少一种正在研究的其他二线结核病治疗药物
- 在研究开始时，根据产妇报告和可用的医疗记录，已经接受了至少两周所需剂量的研究药物。
- 在研究开始时，研究人员评估为在妊娠 20 0/7 - 26 6/7 周（妊娠中期）或妊娠 30 0/7 至 37 6/7 周（妊娠晚期）内完成初始 PK 取样没有确定的障碍并在注册后 14 天内。
- 在研究开始时，如果收到正在研究的药物的通用配方，则根据研究方案批准配方。
第 5 部分：接受口服抗逆转录病毒药物的产后 WLHIV 母乳喂养及其婴儿
- 母亲已达到法定年龄或能够根据研究中心 SOP 提供独立的知情同意书并符合研究中心 IRB/EC 政策和程序，并且愿意并能够为她自己和她的婴儿参与本研究提供书面知情同意书。
- 在进入研究之前，根据研究方案，HIV 状态确认为 HIV 感染。
- 在研究开始时，分娩后 5-9 天内（含）。
- 在研究开始时，母乳喂养的母婴对打算在分娩后至少 16 周内继续纯母乳喂养。
在研究开始时，母亲正在接受以下任何一种口服抗逆转录病毒药物或药物组合：
- 5.1 组：阿扎那韦/利托那韦 (ATV/r)
- 5.2 组：达芦那韦/利托那韦 (DRV/r)
- 5.3 组：洛匹那韦/利托那韦 (LPV/r)
- 在研究开始时，根据母体报告和可用的医疗记录，母亲已经以所需剂量接受研究中的药物或药物组合至少两周。
- 在研究开始时，由研究人员评估为在交付后 5-9 天的 PK 取样窗口内没有确定完成初始 PK 取样的障碍。
- 在研究开始时，根据母亲的报告和可用的医疗记录，母亲计划在分娩后至少 16 周内继续目前的 ARV 方案。
- 在研究开始时，如果接受正在研究的药物或药物组合的通用 ARV 制剂，则根据研究方案批准制剂。
- 根据可用的医疗记录，在研究开始时，婴儿体重至少为 1000 克。
- 根据现场调查员的判断，在进入研究时，婴儿没有任何严重的先天性畸形或与生活不相容或会干扰研究参与或解释的其他医学状况。
组分 1-4 排除标准：
根据母亲的报告和可用的医疗记录，在研究开始时，母亲在过去 14 天内接受过已知会干扰正在研究的药物或药物组合（参见研究方案）的吸收、代谢或清除的药物。
- 注意：对于正在评估 TB 和 ARV 药物相互作用的组件 3 和 4 中的母亲，RIF 是允许的。
- 在研究开始时，现场调查员认为有临床或实验室发现或情况可能需要在研究随访期间更换研究中的 ARV 或 TB 药物。
- 仅第 1.3、1.4 和 1.5 组：在研究开始时，母亲在过去 6 个月内接受过基于 TDF 的治疗。
成分 5 排除标准
- 母亲目前正在参加第 1、2、3 或 4 部分。
- 在研究开始时，母亲或婴儿在过去 14 天内接受过根据母体报告和可用医疗记录（参见研究方案）已知会干扰正在研究的药物或药物组合的吸收、代谢或清除的药物。
- 在研究开始时，母亲或婴儿有临床或实验室发现或病症，现场研究者认为可能需要在研究随访期间更换研究药物。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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组分 1：Arm 1.1：Bictegravir (BIC) 50 mg q.d.
妊娠 ≥ 20 周且未接受抗结核药物治疗且每天一次（q.d.）接受比克替拉韦 (BIC) 50 mg 的女性及其婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组分 1：Arm 1.2：Doravirine (DOR) 100 mg q.d.
妊娠≥ 20 周且未接受抗结核药物治疗且接受 doravirine (DOR) 100 mg q.d. 的女性及其婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组分 1：第 1.4 组：TAF 25 mg q.d.没有提升
妊娠≥ 20 周未接受抗结核药物治疗且接受 TAF 25 mg q.d. 的女性
没有助推器，他们的婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组分 1：第 1.5 组：TAF 25 mg q.d.提升
妊娠≥ 20 周未接受抗结核药物治疗且接受 TAF 25 mg q.d. 的女性
用 cobicistat 或 ritonavir 增强，以及它们的婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组分 3：第 3.1 组：多替拉韦 (DTG) 50 mg
妊娠≥ 20 周的女性接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA)、莫西沙星 (MFX) )，并接受多替拉韦 (DTG) 50 mg 每日两次（b.i.d.）与 RIF 联合使用或 50 mg q.d.
如果 RIF 不是 TB 治疗方案的一部分，那么他们的婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
参与者将接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA) 或莫西沙星 (MFX) . 药物将按照包装说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行给药。 |
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组件 3：Arm 3.2：ATV/r 或 DRV/r
妊娠≥ 20 周的女性接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA)、莫西沙星 (MFX) )，并接受阿扎那韦/利托那韦 (ATV/r) ≥ 300/100 mg q.d.或地瑞那韦/利托那韦 (DRV/r) ≥ 600/100 mg b.i.d.，及其婴儿
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参与者将接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA) 或莫西沙星 (MFX) . 药物将按照包装说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行给药。
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组分 3：第 3.3 组：洛匹那韦/利托那韦 (LPV/r) 800/200 mg
妊娠≥ 20 周的女性接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA)、莫西沙星 (MFX) )，并接受洛匹那韦/利托那韦 (LPV/r) 800/200 mg b.i.d.，以及他们的婴儿
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参与者将接受至少两种以下结核病治疗药物的一线结核病治疗：异烟肼 (INH)、利福平 (RIF)、利福布丁 (RFB)、乙胺丁醇 (EMB)、吡嗪酰胺 (PZA) 或莫西沙星 (MFX) . 药物将按照包装说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行给药。
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组成部分 4：第 4.1 组：二线结核病治疗药物
接受至少一种以下二线结核病治疗药物的妊娠≥ 20 周的妇女及其婴儿：
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参与者将接受至少一种以下二线结核病治疗药物的二线结核病治疗：
药物将按照包装说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行给药。 |
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组件 5：Arm 5.1：ATV/r
接受 ATV/r 的产后妇女及其婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组件 5：Arm 5.2：DRV/r
接受 DRV/r 的产后妇女及其婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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组件 5：臂 5.3：LPV/r
接受 LPV/r 的产后妇女及其婴儿
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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Component 1: Arm 1.3: Tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat
Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d.
boosted with cobicistat, and their infants
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按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
按照药物说明书和/或向参与者开具或供应药物的非研究来源提供的说明进行管理
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Component 2: Arm 2.1: Long-acting injectable formulation of cabotegravir (CAB LA)
Women ≥ 24 weeks gestation who received at least one dose of long-acting injectable formulation of cabotegravir (CAB LA) any dose during pregnancy, and their infants
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Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Women Who Meet Area Under the Curve (AUC) Target in Plasma (Component 1)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
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A target AUC was derived for each drug as the 10th percentile for the non-pregnant population based on historical control data.
The target AUC is 58.7 mg*h/L for Arm 1.1 and 10.0 mg*h/L for Arm 1.2.
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
McNemar's test was not conducted for Arm 1.2 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
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Median Maternal AUC in Plasma (Component 1)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Wilcoxon signed-rank test was not conducted for Arm 1.2 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
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Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS) (Component 1)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose.
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TFV-DP intracellular concentrations in DBS samples.
Concentrations obtained from two 7 mm punches.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose.
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Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose and at 3 and 24 hours post-dose.
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TFV-DP intracellular concentrations in PBMC samples.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose and at 3 and 24 hours post-dose.
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Median Maternal Isoniazid (INH) AUC in Plasma (Component 3)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Rifampin (RIF) AUC in Plasma (Component 3)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Ethambutol (EMB) AUC in Plasma (Component 3)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Pyrazinamide (PZA) AUC in Plasma (Component 3)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
Comparison of Antepartum vs. Postpartum was not done due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 3)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
The data of the P1026s arm was not reported since it's not one of the arms in this study.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Bedqauiline (BDQ) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Clofazimine (CFZ) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Delamanid (DLM) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Levofloxacin (LFX) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Linezolid (LZD) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
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Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
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Median Maternal Atazanavir (ATV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5)
大体时间：Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
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Breast milk and maternal plasma concentrations were collected at study visits and compared as a ratio.
A higher ratio indicates the potential for higher infant drug exposure through breast milk.
Only measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.
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Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
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Median Maternal Ritonavir (RTV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5)
大体时间：Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
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Breast milk and maternal plasma concentrations were collected at study visits and compared as a ratio.
A higher ratio indicates the potential for higher infant drug exposure through breast milk.
Only measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.
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Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
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Infant Atazanvir (ATV) Plasma Concentration (Component 5)
大体时间：Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
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Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol.
The lower limit of quantitation (LLoQ) was 23.4 ng/mL for ATV.
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Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
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Infant Ritonavir (RTV) Plasma Concentration (Component 5)
大体时间：Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
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Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol.
The lower limit of quantitation (LLoQ) was 9.8 ng/mL for RTV.
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Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.1 and 1.2)
大体时间：Measured at time of delivery with single cord blood and single maternal blood sample.
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Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio.
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Measured at time of delivery with single cord blood and single maternal blood sample.
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Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4)
大体时间：Measured at time of delivery with single cord blood and single maternal blood sample.
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Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio.
There are four analytes for Arms 1.3 and 1.4: tenofovir alafenamide fumarate (TAF) in plasma, tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS), TFV-DP in peripheral blood mononuclear cells (PBMCs), and tenofovir (TFV) in plasma.
For Arm 1.3 TAF in plasma, all values were below the lower level of quantitation.
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Measured at time of delivery with single cord blood and single maternal blood sample.
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Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3)
大体时间：Measured at time of delivery with single cord blood and single maternal blood sample.
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Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio.
The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).
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Measured at time of delivery with single cord blood and single maternal blood sample.
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Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 4)
大体时间：Measured at time of delivery with single cord blood and single maternal blood sample.
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Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio.
The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).
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Measured at time of delivery with single cord blood and single maternal blood sample.
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Median Infant Washout Half-life of Drug After Birth (Component 1)
大体时间：Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Infant washout PK concentrations were measured during the first 9 days of life.
Half-life was calculated based on the concentrations.
The analyte of Arm 1.4 is tenofovir in plasma.
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Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Infant Washout Half-life of Drug After Birth (Component 3)
大体时间：Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Infant washout PK concentrations were measured during the first 9 days of life.
Half-life was calculated based on the concentrations.
The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).
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Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Infant Washout Half-life of Drug After Birth (Component 4)
大体时间：Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Infant washout PK concentrations were measured during the first 9 days of life.
Half-life was calculated based on the concentrations where it was possible to calculate.
The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).
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Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
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Maternal Breast Milk/Maternal Plasma Concentration Ratio (Components 3 and 4)
大体时间：Measured at 2-8 weeks postpartum (and 5-9 days and 16-24 weeks post-delivery if the requirements for breast milk transfer PK sampling are met)
|
Breast milk and maternal plasma concentrations were collected at study visits to be compared as a ratio, measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.
A higher ratio indicates the potential for higher infant drug exposure through breast milk.
Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1.
For Arm 4.1, samples were collected but not run and have yet to be analyzed.
The anticipated reporting date is April 2027.
|
Measured at 2-8 weeks postpartum (and 5-9 days and 16-24 weeks post-delivery if the requirements for breast milk transfer PK sampling are met)
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Infant Plasma Concentration (Component 3)
大体时间：Measured through Week 24
|
Plasma concentrations as part of breast milk transfer sampling.
Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1.
|
Measured through Week 24
|
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Median Infant Bedaquiline (BDQ) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
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Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
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Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
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Median Infant Clofazimine (CFZ) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
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Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
|
Median Infant Delamanid (DLM) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
|
Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
|
Median Infant Levofloxacin (LFX) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
|
Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
|
Median Infant Linezolid (LZD) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
|
Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
|
Median Infant Dolutegravir (DTG) Plasma Concentration (Component 4)
大体时间：Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
|
Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
|
|
Median Maternal Efavirenz (EFV) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
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Median Maternal Lopinavir (LPV) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
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Median Median Atazanavir (ATV) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
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Median Maternal Darunavir (DRV) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
|
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
AUC reported is the AUC to the last measurable timepoint.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
|
|
Median Maternal Raltegravir (RAL) AUC in Plasma (Component 4)
大体时间：Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
|
Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
|
|
Number of Participants With Grade 3 or Higher Maternal Adverse Events
大体时间：Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
Maternal Grade 3 or higher adverse events.
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
|
Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
|
Number of Participants With Grade 2 or Higher Infant Adverse Events
大体时间：Measured from entry through Week 24
|
Infant Grade 2 or higher adverse events.
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
|
Measured from entry through Week 24
|
|
Number of Participants With Maternal Serious Adverse Events
大体时间：Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
Maternal serious adverse events which were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
|
Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
|
Number of Participants With Infant Serious Adverse Events
大体时间：Measured from entry through Week 24
|
Infant serious adverse events.
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
|
Measured from entry through Week 24
|
|
Number of Participants With Grade 3 or Higher Maternal Adverse Events Assessed as Related to the Drug Under Study
大体时间：Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
Maternal Grade 3 or higher adverse events assessed as related to the drug under study.
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
|
Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
|
|
Number of Participants With Grade 2 or Higher Infant Adverse Events Assessed as Related to the Drug Under Study
大体时间：Measured from entry through Week 24
|
Infant Grade 2 or higher adverse events assessed as related to the drug under study.
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
|
Measured from entry through Week 24
|
|
Pregnancy Outcome
大体时间：Measured on maternal delivery date/infant Day 0
|
Outcome of pregnancy categorized as live birth, stillbirth, spontaneous abortion, and etc.
|
Measured on maternal delivery date/infant Day 0
|
|
Median Gestational Age at Birth
大体时间：Measured on Day 0 (0-3 days)
|
Infant gestational age at birth (weeks)
|
Measured on Day 0 (0-3 days)
|
|
Median Infant Birth Weight
大体时间：Measured on Day 0 (0-3 days)
|
Infant birth weight (grams)
|
Measured on Day 0 (0-3 days)
|
|
Occurrence of Congenital Anomaly or Mitochondrial Disorder
大体时间：Measured from Day 0 through Week 24 for Components 1, 3, 4 and 5; measured from Day 0 through Week 5 for Component 2
|
Presence of any congenital anomaly or mitochondrial disorder identified in infants.
|
Measured from Day 0 through Week 24 for Components 1, 3, 4 and 5; measured from Day 0 through Week 5 for Component 2
|
|
Infant HIV Status
大体时间：Measured from Day 0 through Week 24
|
Infant HIV status which is determined according to diagnosis per local standard of care
|
Measured from Day 0 through Week 24
|
|
Maternal HIV-1 RNA
大体时间：Measured in 2nd Trimester,(2T, 20 0/7 to 26 6/7 weeks of pregnancy), 3rd Trimester (3T, 30 0/7 to 37 6/7 weeks of pregnancy), delivery, and PP (2-8 weeks or 6-12 weeks after delivery, depending on study arm)
|
Plasma HIV-1 RNA levels in the mothers as in categories.
The highest value of the lower limits of quantitation (LLoQ) for each arm was used for categorizations.
The LLoQs are: Arm 1.1 - 40 copies/mL, Arm 1.2 - 20 copies/mL, Arm 1.3 and Arm 1.4 - 200 copies/mL, Arm 3.1 - 40 copies/mL, and Arm 4.1 - 50 copies/mL.
|
Measured in 2nd Trimester,(2T, 20 0/7 to 26 6/7 weeks of pregnancy), 3rd Trimester (3T, 30 0/7 to 37 6/7 weeks of pregnancy), delivery, and PP (2-8 weeks or 6-12 weeks after delivery, depending on study arm)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Mark Mirochnick, MD、Boston University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年9月1日
初级完成 (实际的)
2025年4月24日
研究完成 (实际的)
2025年7月10日
研究注册日期
首次提交
2020年3月5日
首先提交符合 QC 标准的
2020年8月14日
首次发布 (实际的)
2020年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IMPAACT 2026
- 38609 (注册表标识符：DAIDS-ES Registry Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
在去标识化后，作为出版物结果基础的个人参与者数据。
IPD 共享时间框架
从出版后 3 个月开始，在 NIH 的国际母婴青少年艾滋病临床试验 (IMPAACT) 网络资助期间可用。
IPD 共享访问标准
和谁一起？
- 为使用经 IMPAACT 网络批准的数据提供方法论合理建议的研究人员。
用于什么类型的分析？
- 实现 IMPAACT 网络批准的提案中的目标。
将通过什么机制提供数据？
- 研究人员可以使用 IMPAACT“数据请求”表格提交访问数据的请求：https://www.impaactnetwork.org/resources/study-proposals.htm。 获批提案的研究人员在收到数据之前需要签署 IMPAACT 数据使用协议
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.