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Completed

NCT Number: NCT02020083

Placental Transfer of Tenofovir

The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

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Key information

Conditions

Pregnant Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maternité de Port Royal

Paris, France

About this study

Nowadays, mother-to-child HIV transmission is the main cause of paediatric HIV infections. Yet, this way of transmission is effectively limited by the use of antiretroviral therapies during pregnancy in HIV infected women. The study TEmAA (ANRS 12109) we conducted allowed us to suggest a therapeutic scheme of administration of the association tenofovir disoproxil fumarate (TDF) - emtricitabine (FTC) to reduce the risk of postpartum resistance that may occur with the administration of a single dose of nevirapine before delivery. However, we also observed a large interindividual variability of TDF in vivo placental transfer that remained unexplained. Placental membrane transporters, including efflux transporters belonging the ABC transporter superfamily and uptake transporters, may constitute a source of variability. In this case, we showed such an association for maraviroc with a significant inverse correlation between its clearance index and the placental expression level of several efflux transporters of the ABCC/MRP family. Regarding TDF, it has been shown that this drug is a substrate of several efflux transporters (ABCC2/MRP2, ABCC4/MRP4, ABCC10/MRP7) and an uptake transporter (hOAT3). As these transporters are expressed on the placental barrier, it may be hypothesized that their expression levels could contribute to modulate the placental transfer of this drug. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy. Our first aim is to evaluate the potential effect of ABCC2, ABCC4, ABCC10 and hOAT3 placental expression on TDF placental transfer (First year). We also want to investigate whether a potential interaction between TDF and FTC could take part to variability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Major Patients > or = 18 years old
  • At term between 37 and 41 weeks of gestational age
  • Uncomplicated pregnancy
  • Informed Consent Form signed

Exclusion criteria

  • Women HIV+, HBV+ or HBC+
  • Women with cardiovascular diseases such as diabetes or preeclampsia, IUGR
  • Women who had taken medications during pregnancy

Treatment and study plan

Primary outcomes

  1. Determination of ABC transporters gene expression levels by quantitative RT-PCR

    Time frame: 1 hour

    Placental villi were extracted To study the expression level of transporters that may affect the placental transfer. Gene expression was evaluated for each sample using the cycle threshold value (CT), defined as the fraction cycle number at which the fluorescence generated by SYBR green dye-amplicon complex formation passes a fixed threshold above the baseline.

Secondary outcomes

  1. Fetal transfer rate (%)of emtricitabine alone, or Tenofovir alone, or in association

    Time frame: 3 hours

    Placental perfusion with Emtricitabine alone, then with Tenofovir alone, and together. Fetal transfer rate of (FTR) was calculated as follow : (Cf*Vf)*100/ ((Cf*Vf)+(Cm*Vm))where Cf denotes the fetal concentration, Vf, the volume of fetal perfusate, Cm, the maternal concentration and Vm, the volume maternal perfusate.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model

Acronym: TDF-PTP

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2013
Registry last updated
Feb 13, 2026

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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