Placental Transfer of Tenofovir

NCT02020083 | Completed

• 1 other identifier: NI121204
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnant Women

Keywords

VIH ; Placental transfer ; Tenofovir ; Emtricitabine ; Membrane transporter

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 hour

Secondary Outcomes (1)

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

  3 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women (at term \>37 to 41 weeks of gestational age) without complications during pregnancy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Maternité de Port Royal

Paris, France

Location

Related Publications (2)

• Hirt D, Urien S, Ekouevi DK, Rey E, Arrive E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Treluyer JM; ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther. 2009 Feb;85(2):182-9. doi: 10.1038/clpt.2008.201. Epub 2008 Nov 5.

  PMID: 18987623 BACKGROUND

• Vinot C, Gavard L, Treluyer JM, Manceau S, Courbon E, Scherrmann JM, Decleves X, Duro D, Peytavin G, Mandelbrot L, Giraud C. Placental transfer of maraviroc in an ex vivo human cotyledon perfusion model and influence of ABC transporter expression. Antimicrob Agents Chemother. 2013 Mar;57(3):1415-20. doi: 10.1128/AAC.01821-12. Epub 2013 Jan 7.

  PMID: 23295922 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples will be collected. The expression levels of several efflux transporters (ABCC2/MRP2, ABCC4/MRP4, ABCC10/MRP7) and an uptake transporter (hOAT3) will be determined to explain the variability of placental transfer.

Study Officials

• Jean Marc Treluyer, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: December 24, 2013
• Study Start: February 1, 2013
• Primary Completion: June 4, 2020
• Study Completion: June 30, 2020
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (1)