Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Recruiting now
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00825929
- Run by
- Radboud University Medical Center
- People needed
- 176
- Starts
- 2009-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Saint-Pierre University Hospital; Department of Infectious Diseases — Brussels, Belgium (enrolling)
- CHARITÉ Berlin — Berlin, Germany (enrolling)
- University of Bonn — Bonn, Germany (enrolling)
- University of Cologne — Cologne, Germany (enrolling)
- Johann Wolfgang Goethe-Universität — Frankfurt am Main, Germany (enrolling)
- University München — München, Germany (enrolling)
- Mater Hospital and UCD — Dublin, Ireland (enrolling)
- St James's Hospital Dublin — Dublin, Ireland (enrolling)
- Hospital Universitari Germans Trias i Pujol, Badalona — Badalona, Spain (enrolling)
- Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna — Granada, Spain (enrolling)
- Brighton and Sussex University Hospitals NHS Trust — Brighton, United Kingdom (enrolling)
- C&W Hospital, London — London, United Kingdom (enrolling)
- St Mary's Hospital, London — London, United Kingdom (enrolling)
- Radboud University Nijmegen Medical Centre — Nijmegen, Netherlands (enrolling)
- Erasmus Medical Center Rotterdam — Rotterdam, Netherlands (enrolling)
- St Elisabeth hospital — Tilburg, Netherlands (enrolling)
- IRCSS — Rome, Italy
- AMC — Amsterdam, Netherlands
- St Thomas Hospital — London, United Kingdom
- North Middlesex Hospital — London, United Kingdom
- St. George's Hospital, London — London, United Kingdom
Full record on ClinicalTrials.gov
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