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Understanding how HIV medications work in pregnant women

Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

Observational Radboud University Medical Center · NCT00825929

This study is testing how HIV medications work in pregnant women during the third trimester to see if we can improve their treatment.

Quick facts

Study typeObservational
Enrollment176 (estimated)
Ages18 Years and up
SexFemale
SponsorRadboud University Medical Center Academic / other
Drugs / interventionscART
Locations21 sites (Brussels and 20 other locations)
Trial IDNCT00825929 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-infected pregnant women who are at least 18 years old and have been on a cART regimen containing specific antiretroviral agents for at least two weeks.

Not a fit: Patients who are not pregnant or those with conditions that interfere with drug metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dosing guidelines for antiretroviral medications in pregnant women, enhancing treatment efficacy and safety for both mothers and their infants.

How similar studies have performed: While pharmacokinetic studies in general have been conducted, this specific focus on pregnant women and the range of antiretroviral agents is relatively novel and underexplored.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Brussels and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV InfectionspharmacokineticspregnancyantiretroviralsneonatesHIVtreatment experienced
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.