Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Recruiting · NCT00825929 · Observational (researchers observe without assigning treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
21 locations listed.
- AMC - Amsterdam, Netherlands
- Hospital Universitari Germans Trias i Pujol, Badalona - Badalona, Spain
- CHARITÉ Berlin - Berlin, Germany
- University of Bonn - Bonn, Germany
- Brighton and Sussex University Hospitals NHS Trust - Brighton, United Kingdom
- Saint-Pierre University Hospital; Department of Infectious Diseases - Brussels, Belgium
- University of Cologne - Cologne, Germany
- Mater Hospital and UCD - Dublin, Ireland
- St James's Hospital Dublin - Dublin, Ireland
- Johann Wolfgang Goethe-Universität - Frankfurt am Main, Germany
- Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna - Granada, Spain
- C&W Hospital, London - London, United Kingdom
- North Middlesex Hospital - London, United Kingdom
- St Mary's Hospital, London - London, United Kingdom
- St Thomas Hospital - London, United Kingdom
- St. George's Hospital, London - London, United Kingdom
- University München - München, Germany
- Radboud University Nijmegen Medical Centre - Nijmegen, Netherlands
- IRCSS - Rome, Italy
- Erasmus Medical Center Rotterdam - Rotterdam, Netherlands
- St Elisabeth hospital - Tilburg, Netherlands