Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
- Conditions
- HIV Infections
- Registration Number
- NCT00825929
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 176
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (21)
Saint-Pierre University Hospital; Department of Infectious Diseases
🇧🇪Brussels, Belgium
CHARITÉ Berlin
🇩🇪Berlin, Germany
University of Bonn
🇩🇪Bonn, Germany
University of Cologne
🇩🇪Cologne, Germany
Johann Wolfgang Goethe-Universität
🇩🇪Frankfurt am Main, Germany
University München
🇩🇪München, Germany
Mater Hospital and UCD
🇮🇪Dublin, Ireland
St James's Hospital Dublin
🇮🇪Dublin, Ireland
IRCSS
🇮🇹Rome, Italy
AMC
🇳🇱Amsterdam, Netherlands
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Erasmus Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
St Elisabeth hospital
🇳🇱Tilburg, Netherlands
Hospital Universitari Germans Trias i Pujol, Badalona
🇪🇸Badalona, Spain
Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna
🇪🇸Granada, Spain
St Mary's Hospital, London
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
St. George's Hospital, London
🇬🇧London, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
C&W Hospital, London
🇬🇧London, United Kingdom
North Middlesex Hospital
🇬🇧London, United Kingdom