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

NCT ID: NCT05751031

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2024-02-20

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

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

Raltegravir

Intervention Type DRUG

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

Interventions

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Raltegravir

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UCL Great Ormond Street Institute of Child Health

OTHER

Sponsor Role collaborator

Fondazione Penta UK

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Thorne

Role: STUDY_CHAIR

Professor of infectious disease epidemiology

Locations

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Centre Hospitalier Universitaire Saint Pierre

Brussels, , Belgium

Site Status RECRUITING

Università degli studi di Firenze

Florence, , Italy

Site Status RECRUITING

"Victor Babes" Hospital

Bucharest, , Romania

Site Status RECRUITING

State Budgetary Institution of Health Protection Irkutsk

Arkhangelsk, , Russia

Site Status COMPLETED

St Petersburg Republican Hospital

Saint Petersburg, , Russia

Site Status COMPLETED

St. Petersburg State Budgetary Health Institution

Saint Petersburg, , Russia

Site Status COMPLETED

Hospital San Joan de Deu

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

University College London

London, , United Kingdom

Site Status RECRUITING

Countries

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Belgium Italy Romania Russia Spain Switzerland United Kingdom

Central Contacts

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Giorgia Dalla Valle

Role: CONTACT

+39 049 821 5447

Facility Contacts

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Philippe Leroy

Role: primary

Luisa Galli

Role: primary

Luminita Ene

Role: primary

Claudia Fortuny Guasch

Role: primary

Luis Prieto Tato

Role: primary

Christian Kahlert

Role: primary

Claire Thorne

Role: primary

Other Identifiers

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Raltegravir

Identifier Type: -

Identifier Source: org_study_id

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