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

NCT05751031 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2023-03-02

No results posted yet for this 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.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir

Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated.

Sponsors & Collaborators

  • UCL Great Ormond Street Institute of Child Health

    collaborator OTHER

  • Fondazione Penta UK

    lead NETWORK

Principal Investigators

  • Claire Thorne · Professor of infectious disease epidemiology

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • Belgium
  • Italy
  • Romania
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751031 on ClinicalTrials.gov