Actively Recruiting

Age: 18Years +
FEMALE
ID00825929

Pharmacokinetics of New Antiretroviral Agents in HIV-Infected Pregnant Women Study on Drug Levels During and After Pregnancy (PANNA)

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

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

Official Title

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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Research Team

D

David M Burger, PharmD PhD

W

Wendy van der Wekken, MSc

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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Published Research Related To This Trial

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/23169329

The Effect of Pregnancy on the Pharmacokinetics of Total and Unbound Dolutegravir and Its Main Metabolite in Women Living With Human Immunodeficiency Virus.

Pauline Bollen, Jolien Freriksen, Deborah Konopnicki...

https://pubmed.ncbi.nlm.nih.gov/32103260

Population Pharmacokinetics of Cobicistat and its Effect on the Pharmacokinetics of the Anticancer Drug Olaparib.

Joanneke K Overbeek, Nielka P van Erp, David M Burger...

https://pubmed.ncbi.nlm.nih.gov/39909979

Clinically Significant Lower Elvitegravir Exposure During the Third Trimester of Pregnant Patients Living With Human Immunodeficiency Virus: Data From the Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) Network.

Vera Bukkems, Coca Necsoi, Carmen Hidalgo Tenorio...

https://pubmed.ncbi.nlm.nih.gov/32330231

Lowered Rilpivirine Exposure During the Third Trimester of Pregnancy in Human Immunodeficiency Virus Type 1-Infected Women.

Stein Schalkwijk, Angela Colbers, Deborah Konopnicki...

https://pubmed.ncbi.nlm.nih.gov/28595298