Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) - PANNA

Radboud university medical center0 个研究点目标入组 230 人开始时间: 2010年2月16日最近更新: 2024年2月26日

研究概览

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•1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
•2. Subject is at least 18 years of age at screening.
•3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
•4. Treated with an HAART 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.
•5. Subject is pregnant
•6. Subject is able to adhere to food intake recommendations.
•7. For raltegravir QD sub-study only: treated with a cART regimen containing raltegravir, or intention of the treating physician to add raltegravir to the cART regimen during pregnancy.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 16
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 230
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
•2. Inability to understand the nature and extent of the study and the procedures required.
•3. Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)
•4. Using oral cabotegravir/rilpivirine.

发起方