PER-026-14已完成未知
PHARMACOLOGY SUBSTADIES OF A5263 AND A5264
Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU, Instituto Nacional de Cancer (NCI). EEUU,0 个研究点目标入组 3 人开始时间: 2014年5月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 3
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
- 18 至 75（—）
- 性别
- All
入选标准
- •Women and men participants of A5263 and A5264 that accomplished with the following criteria:
- •Inclusion Criteria Step 1
- •1.Current enrollment in Arms 1A, 1B, or 1C of A5263 or Arms 1A or 1B of A5264.
- •2.Participant must be able to complete PK sampling within the following acceptable windows:
- •For A5263 Arm 1A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen).
- •A5263 Arm 1B, PK sampling will be performed at a protocol scheduled clinic visit on first dosing day of 2nd BV cycle (with concomitant administration of the ART regimen). PK sampling may be performed on first dosing day of 1st BV cycle if participant has been receiving EFV/TDF/FTC for at least 5 days.
- •For A5263 Arm 1C, PK sampling will be performed at a protocol scheduled clinic visit on dose day of 2nd PTX cycle (with concomitant administration of the ART regimen). PK sampling may be performed on dose day of 1st PTX cycle if participant has been receiving EFV/TDF/FTC for at least 5 days.
- •For A5264 Arm 1A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) after the start of the ART regimen.
- •For A5264 Arm 1B, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen).
- •3.Current use of EFV/TDF/FTC.
- •4.Ability and willingness of participant or legal guardian/representative to provide informed consent
- •Inclusion Criteria Step 2
- •1.Current enrollment in Step 2 of A5264.
- •2.Participant must be able to complete PK sampling within the following acceptable windows:
- •For A5264 Arm 2A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen).
- •3.Current use of EFV/TDF/FTC.
排除标准
- •Not applicable, the participants are the main study
研究者
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