Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 21
- 主要终点
- Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery
研究概览
简要总结
Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.
详细描述
The following agents will be studied:
Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir; cabotegravir/rilpivirine long acting injectables
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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-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
Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery
时间窗: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
次要结局
- Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.(Week 1, 3 and between 4 and 6)
- Safety of antiretrovirals during pregnancy(GA Week 33 until end of trial)
- viral load response and prevention of mother to child transmission of the virus(GA Week 3 and at delivery)