PANNA

The PANNA study is a study with the purpose of collecting pharmacokinetic data (PK curves) in pregnant HIV-infected women using newly developed antiretroviral agents.

About the study

The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents during pregnancy for which no or only limited pharmacokinetic data during pregnancy are available. Pharmacokinetic curves will be collected in the 2nd (raltegravir QD and dolutegravir) 3rd trimester of pregnant HIV-infected women and at 4-6 weeks post-partum. In addition, the pharmacokinetics will be determined in the infant as well, in case of post-exposure prophylaxis with one of the agents tested.

The secondary objective of this study is to describe the safety of the antiretroviral agents during pregnancy and the efficacy in terms of viral load response of the mother and prevention of mother-to-child transmission.
included patients

Rationale

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.

Antiretroviral agents under study

  • Bictegravir, Biktarvy®, 50/200/25mg BIC/FTC/TAF (integrase inhib)
  • Doravirine, Pifeltro/Delstrigo®, 100mg QD (NNRTI)
  • Raltegravir, Isentress®, 1200mg QD (integrase inhib)
  • Fosamprenavir, Telzir®, FPV (PI)
  • Tipranavir, Aptivus®, TPV (PI)
  • Indinavir, Crixivan® (PI)
  • Enfuvirtide, Fuzeon® (entry inhibitor)
  • Cabotegravir (Vocabria®), rilpivirine (Rekambys®)

Latest publication

Total number of peer reviewed publications: 23

Total number of posters/presentations at international conferences: 30

 

Latest publication in CID:  Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network.

For all publications see Publications.

Sponsors

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