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

Recruiting

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir

• Registration Number: NCT05751031
• Lead Sponsor: Fondazione Penta UK

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-20
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patterns of antenatal use	12 months	To describe patterns of antenatal use of RAL-containing regimens, including maternal characteristics, timing of initiation, NRTI backbone/other drugs in regimen and calendar time trends
Frequency of averse birth outcomes	12 months	To describe the frequency of adverse birth outcomes in RAL-exposed pregnancies including birth defects, stillbirths, preterm births, low birth weight infants, and small-for-gestational age infants, by timing of exposure
Birth defects per trimester of exposure	12 months	To compare risk of birth defects in infants with peri-conception and/or first trimester exposure to RAL with that in infants with exposure to RAL from the second or third trimester

Secondary Outcome Measures

Name	Time	Method
Viral suppression	12 months	To describe the proportion of women on RAL who achieve viral suppression by the end of pregnancy and the vertical transmission rate in mother-infants pairs with RAL use
Frequency of discontinuation	12 months	To assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available.

Trial Locations

Locations (10)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Università degli studi di Firenze; 🇮🇹 Firenze, Italy

University College London; 🇬🇧 London, United Kingdom

Centre Hospitalier Universitaire Saint Pierre; 🇧🇪 Brussels, Belgium

St Petersburg Republican Hospital; 🇷🇺 Saint Petersburg, Russian Federation

"Victor Babes" Hospital; 🇷🇴 Bucharest, Romania

St. Petersburg State Budgetary Health Institution; 🇷🇺 Saint Petersburg, Russian Federation

State Budgetary Institution of Health Protection Irkutsk; 🇷🇺 Arkhangelsk, Russian Federation

Hospital San Joan de Deu; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain