Studies how HIV medicines move through the body in pregnant women
Measures how antiretroviral medicines act in HIV-infected women during late pregnancy.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Key facts
- Where
- Amsterdam, Groningen, Nijmegen, Rotterdam, Tilburg, and Utrecht, NetherlandsSee the 6 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT00825929, who can take part
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsNo longer taking part
- Universitair Medisch Centrum GroningenGroningen, NetherlandsNo longer taking part
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsNo longer taking part
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsNo longer taking part
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, NetherlandsNo longer taking part
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT00825929EU 2024-515487-31-00
- Record updated
- 13 January 2025
- Original description
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.Read full original descriptionShow less
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
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.
Inclusion: 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.
Exclusion: Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion; Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL); Inability to understand the nature and extent of the study and the procedures required; Using oral cabotegravir/rilpivirine.