Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Conditions

HIV Infections

Keywords

pharmacokinetics, pregnancy, antiretrovirals, neonates, HIV, treatment experienced

Brief summary

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.

Detailed description

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

Overbeek JK, van Erp NP, Burger DM, den Broeder AA, Koolen SLW, Huitema ADR, Ter Heine R.

2025-02-05

10.1007/s40262-025-01480-w

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Maren I. Blonk, Angela Colbers, Carmen Hidalgo-Tenorio, Kabamba Kabeya, Katharina Weizsäcker et al. (14 authors)

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Colbers A, Moltó J, Ivanovic J, Kabeya K, Hawkins D, Gingelmaier A, Taylor G, Weizsäcker K, Sadiq ST, Van der Ende M, Giaquinto C, Burger D, PANNA Network.

2014-10-1731 citations

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Atazanavir Exposure is Effective during Pregnancy Regardless of Tenofovir Use

Angela Colbers, David Hawkins, Carmen Hidalgo-Tenorio, Marchina van der Ende, Andrea Gingelmaier et al. (17 authors)

Antiviral Therapy2014-07-0316 citations

10.3851/imp2820

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery	PK curve in Week 33 of pregnancy and 4-6 weeks after delivery

Secondary

Measure	Time frame
Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.	Week 1, 3 and between 4 and 6
Safety of antiretrovirals during pregnancy	GA Week 33 until end of trial
viral load response and prevention of mother to child transmission of the virus	GA Week 3 and at delivery

Countries

Belgium, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom

Contacts

Primary ContactDavid M Burger, PharmD PhD

david.burger@radboudumc.nl++31 24 3616405

Backup ContactWendy van der Wekken, MSc

Outcome results