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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751031
• Other study ID #: Raltegravir
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2023
• Source: PENTA Foundation
• Contact: Giorgia Dalla Valle
• Phone: +39 049 821 5447
• Email: giorgia.dallavalle[@]pentafoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire Saint Pierre	Brussels
Italy	Università degli studi di Firenze	Firenze
Romania	"Victor Babes" Hospital	Bucharest
Russian Federation	State Budgetary Institution of Health Protection Irkutsk	Arkhangelsk
Russian Federation	St Petersburg Republican Hospital	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Health Institution	Saint Petersburg
Spain	Hospital San Joan de Deu	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	University Hospital Zurich	Zürich
United Kingdom	University College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Penta UK	UCL Great Ormond Street Institute of Child Health

Countries where clinical trial is conducted

Belgium,  Italy,  Romania,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of antenatal use	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	12 months
Primary	Frequency of averse birth outcomes	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	12 months
Primary	Birth defects per trimester of exposure	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	12 months
Secondary	Frequency of discontinuation	To assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available.	12 months
Secondary	Viral suppression	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	12 months