Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Last updated: February 20, 2023
Sponsor: Fondazione Penta UK
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT05751031
Raltegravir
  • Female

Study Summary

Raltegravir is the preferred INSTI for for treatment of antiretroviral-naïve pregnant women in the US Perinatal Guidelines, alongside Dolutegravir, and for late pregnancy. There are relatively limited information available on its use during early pregnancy, particularly the peri-conception period. The aim of the study is to assess "real-world" maternal, fetal and newborn outcomes following RAL use during pregnancy through pooled analysis of individual patient data from observational studies participating in the European Pregnancy and Paediatric Infections Cohort Collaboration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • pregnant women living with HIV, exposed to Raltegravir at any time during thepregnancy participating in EPPICC and their infants.

Exclusion

Exclusion Criteria:

  • see inclusion

Study Design

Total Participants: 1200
Study Start date:
February 20, 2023
Estimated Completion Date:
February 20, 2024

Connect with a study center

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels,
    Belgium

    Active - Recruiting

  • Università degli studi di Firenze

    Firenze,
    Italy

    Active - Recruiting

  • "Victor Babes" Hospital

    Bucharest,
    Romania

    Active - Recruiting

  • State Budgetary Institution of Health Protection Irkutsk

    Arkhangelsk,
    Russian Federation

    Completed

  • St Petersburg Republican Hospital

    Saint Petersburg,
    Russian Federation

    Completed

  • St. Petersburg State Budgetary Health Institution

    Saint Petersburg,
    Russian Federation

    Completed

  • Hospital San Joan de Deu

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • University Hospital Zurich

    Zürich,
    Switzerland

    Active - Recruiting

  • University College London

    London,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.