Actively Recruiting
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Led by Radboud University Medical Center · Updated on 2025-01-13
176
Participants Needed
21
Research Sites
930 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
P
PENTA Foundation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV infection confirmed by positive antibody and antigen tests
- At least 18 years old at screening
- Able and willing to sign informed consent before screening
- Receiving combination antiretroviral therapy containing at least one study drug for at least 2 weeks before first pharmacokinetic evaluation
- Currently pregnant
- Able to follow food intake recommendations if required
You will not qualify if you...
- History or current condition affecting drug absorption, distribution, metabolism, or excretion
- Unable to understand the study and required procedures
- Presence of severe anemia (grade III/IV) with hemoglobin less than 4.6 mmol/L or 7.4 g/dL
- Currently using oral cabotegravir/rilpivirine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Saint-Pierre University Hospital; Department of Infectious Diseases
Brussels, Belgium
Actively Recruiting
2
CHARITÉ Berlin
Berlin, Germany
Actively Recruiting
3
University of Bonn
Bonn, Germany
Actively Recruiting
4
University of Cologne
Cologne, Germany
Actively Recruiting
5
Johann Wolfgang Goethe-Universität
Frankfurt am Main, Germany
Actively Recruiting
6
University München
München, Germany
Actively Recruiting
7
Mater Hospital and UCD
Dublin, Ireland
Actively Recruiting
8
St James's Hospital Dublin
Dublin, Ireland
Actively Recruiting
9
IRCSS
Rome, Italy
Completed
10
AMC
Amsterdam, Netherlands
Completed
11
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Actively Recruiting
12
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
Actively Recruiting
13
St Elisabeth hospital
Tilburg, Netherlands
Actively Recruiting
14
Hospital Universitari Germans Trias i Pujol, Badalona
Badalona, Spain
Actively Recruiting
15
Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna
Granada, Spain
Actively Recruiting
16
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom
Actively Recruiting
17
C&W Hospital, London
London, United Kingdom
Actively Recruiting
18
North Middlesex Hospital
London, United Kingdom
Completed
19
St Mary's Hospital, London
London, United Kingdom
Actively Recruiting
20
St Thomas Hospital
London, United Kingdom
Withdrawn
21
St. George's Hospital, London
London, United Kingdom
Completed
Research Team
D
David M Burger, PharmD PhD
CONTACT
W
Wendy van der Wekken, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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