The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
Angela P H Colbers, David A Hawkins, Andrea Gingelmaier...
https://pubmed.ncbi.nlm.nih.gov/23169329Actively Recruiting
Led by Radboud University Medical Center · Updated on 2025-01-13
176
Participants Needed
21
Research Sites
930 weeks
Total Duration
R
Radboud University Medical Center
Lead Sponsor
P
PENTA Foundation
Collaborating Sponsor
This research aims to understand how pregnancy affects the way certain antiretroviral medications behave in the body of HIV-infected pregnant women. Since pregnancy can change how drugs are absorbed and processed, the study focuses on measuring drug levels during pregnancy, especially in the third trimester, when these changes are most noticeable. The goal is to see if current medication doses provide adequate exposure for pregnant women living with HIV. The study will examine a range of antiretroviral agents including Etravirine, Emtricitabine, Tenofovir, Atazanavir, Fosamprenavir, Darunavir, Tipranavir, Indinavir, Abacavir, Raltegravir, Enfuvirtide, Maraviroc, Dolutegravir, Elvitegravir/cobicistat, Rilpivirine, TAF, Darunavir/cobicistat, Doravirine, Bictegravir, and long-acting injectables like Cabotegravir/rilpivirine. Participants must be on a combination antiretroviral therapy (cART) regimen containing at least one of these agents for at least two weeks before the first pharmacokinetic evaluation. The study will record how drug concentrations change in the blood during the third trimester and again 4 to 6 weeks after delivery. Participants will be involved in pharmacokinetic monitoring where blood samples will be taken to measure medication levels. The main outcome measured is the plasma concentration of the drugs during pregnancy compared to after delivery. Participants need to follow food intake recommendations if applicable and provide informed consent. The study is designed to ensure safety by excluding those with conditions affecting drug metabolism or severe anemia. The total duration includes assessments in the third trimester and postpartum period to understand medication exposure throughout this critical time.
CONDITIONS
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
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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
D
David M Burger, PharmD PhD
W
Wendy van der Wekken, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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