Understanding how HIV medications work in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the pharmacokinetics of various antiretroviral agents in HIV-infected pregnant women, particularly focusing on changes that occur during the third trimester. The study will measure how these medications are absorbed, distributed, metabolized, and excreted in this unique population, as existing data on their pharmacokinetics during pregnancy is limited. Participants will be required to be on a combination antiretroviral therapy (cART) regimen for at least two weeks prior to the pharmacokinetic evaluations. The findings could help optimize dosing for pregnant women living with HIV to ensure effective treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
2. Subject is at least 18 years of age at screening.
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. 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.
5. Subject is pregnant
6. Subject is able to adhere to food intake recommendations, if applicable.

Exclusion Criteria:

1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
2. Inability to understand the nature and extent of the study and the procedures required.
3. Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL).
4. Using oral cabotegravir/rilpivirine.

Where it's running

• Saint-Pierre University Hospital; Department of Infectious Diseases
  Brussels, Belgium Recruiting
• CHARITÉ Berlin
  Berlin, Germany Recruiting
• University of Bonn
  Bonn, Germany Recruiting
• University of Cologne
  Cologne, Germany Recruiting
• Johann Wolfgang Goethe-Universität
  Frankfurt am Main, Germany Recruiting
• University München
  München, Germany Recruiting

Study contacts

• Principal investigator: David M Burger, PharmD PhD — Radboud University Medical Centre Nijmegen
• Study coordinator: David M Burger, PharmD PhD
• Email: david.burger@radboudumc.nl
• Phone: ++31 24 3616405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.