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NCT Number: NCT00825929

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Saint-Pierre University Hospital; Department of Infectious Diseases, Brussels, Belgium

Loading trial locations.

About this study

The following agents will be studied:

Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir; cabotegravir/rilpivirine long acting injectables

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery

    Time frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery

Secondary outcomes

  1. Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.

    Time frame: Week 1, 3 and between 4 and 6

  2. Safety of antiretrovirals during pregnancy

    Time frame: GA Week 33 until end of trial

  3. viral load response and prevention of mother to child transmission of the virus

    Time frame: GA Week 3 and at delivery

Study contacts

Contact information is provided by the study sponsor or research team.

David M Burger, PharmD PhD

CONTACT

[email protected]

++31 24 3616405

Wendy van der Wekken, MSc

CONTACT

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Bristol-Myers Squibb
  • Gilead Sciences
  • Janssen Pharmaceutica
  • Merck Sharp & Dohme LLC
  • PENTA Foundation
  • ViiV Healthcare

Registry information

Official study title

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

Acronym: PANNA

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2009
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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