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

Fondazione Penta UK

Status: Enrolling

Conditions: HIV Infections

Treatments: Drug: Raltegravir

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05751031

Raltegravir

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• see inclusion

Trial design

1,200 participants in 1 patient group

European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Description:

Pregnant women living with HIV and their infants from 9 European cohorts and studies within the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Treatment:

Drug: Raltegravir