Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 163
- 试验地点
- 16
- 主要终点
- AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
研究概览
简要总结
The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents for which no or only limited pharmacokinetic data during pregnancy are available, in the 3rd trimester of pregnant HIV-infected women and at post-partum. And in the 2nd trimester for raltegravir once-daily regimen and dolutegravir regimen. In addition, the pharmacokinetics will be determined in the infant as well in case of post-exposure prophylaxis with one of the agents tested (not performed in Germany).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
- •Subject is at least 18 years of age at screening.
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- •Treated with a cART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
- •Subject is pregnant.
- •Subject is able to adhere to food intake recommendations, if applicable.
排除标准
- •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •Inability to understand the nature and extent of the study and the procedures required.
- •Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).
- •Using oral cabotegravir/rilpivirine.
结局指标
主要结局
AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
Ctrough in pregnancy should be above the minimal effective plasma concentration.
Ctrough in pregnancy should be above the minimal effective plasma concentration.
Cord blood/maternal blood concentration ratio at delivery.
Cord blood/maternal blood concentration ratio at delivery.
Determination of half life in infants after in utero exposure if applicable (washout half life).
Determination of half life in infants after in utero exposure if applicable (washout half life).
Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.
Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.
次要结局
- Description of maternal viral suppression during pregnancy and postpartum.
- Description of infection status of infants at birth.
- Description of SAEs and AEs reported during pregnancy and postpartum.
研究者
Angela Colbers
Scientific
Stichting Radboud universitair medisch centrum