NCT05751031

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Fondazione Penta UK · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2023-03-02
• Last updated: 2023-03-02

Locations

10 sites across 7 countries: Belgium, Italy, Romania, Russia, Spain, Switzerland, United Kingdom