NCT00246610已完成4 期
A Phase IV, Non-Randomized, Open-Label Trial Evaluating The Safety Of 625 mg Formulation Of VIRACEPT When Administered To HIV-Infected Women During Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Presence or absence of at least one adverse event related to or possibly related to nelfinavir of Grade 2 or greater severity as defined by the DAIDS Table for Grading of Severity of Adult Adverse Experiences in the gastrointestinal or hepatic category
研究概览
简要总结
This study is an evaluation of the safety of 625 mg formulation when administered to HIV-infected pregnant women from their second trimester through six weeks postpartum. The study will also evaluate the pharmacokinetics of VIRACEPT
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Second trimester of pregnancy
排除标准
- •Major current or prior history of obstetrical complications
- •Serious current medical diseases
- •Evidence of HIV virus resistance to antiretroviral agents
研究组 & 干预措施
Open-label
Experimental
Non-randomized, open-label, single-arm
干预措施: Nelfinavir mesylate, 625 mg (Drug)
结局指标
主要结局
Presence or absence of at least one adverse event related to or possibly related to nelfinavir of Grade 2 or greater severity as defined by the DAIDS Table for Grading of Severity of Adult Adverse Experiences in the gastrointestinal or hepatic category
时间窗: 32 Weeks
次要结局
- Development of primary or active site protease and nucleoside reverse transcriptase inhibitor-associated resistance mutations assessed using standard HIV genotype test on maternal plasma samples(32 Weeks)
- Presence or absence of at least one adverse event of Grade 3 or 4 severity in the hematologic, cardiovascular or metabolic categories defined by DAIDS Table or in the dermatologic category as defined by the Supplemental Toxicity Table(32 Weeks)
- Adverse pregnancy events which cannot be directly attributed to another cause other than study treatment after consultation with Pfizer Clinician and Site Investigator(32 Weeks)
- Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts(32 Weeks)
- 12-hour pharmacokinetic evaluation of nelfinavir(32 Weeks)
- Maternal plasma HIV RNA(32 Weeks)
- Immunologic response as measured by CD4 and CD8 cell count(32 Weeks)
研究者
研究点 (1)
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