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

NCT05751031 | Unknown

• 1 other identifier: Raltegravir
• Study Type: observational
• Target: 1,200
• Locations: 7 countries
• Sites: 10

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Frequency of discontinuation

  12 months

• Viral suppression

  12 months

Study Arms (1)

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)

Drug: Raltegravir

Interventions

Raltegravir DRUG

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

European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women with any exposure to RAL at any time during the pregnancy and their infants will be included in the analysis. With respect to eligibility, we will include any pregnancy reported within the participating studies with any RAL exposure regardless of pregnancy outcome, including those where the pregnancy is still ongoing at the time of the data merger. This analysis will be based on two EPPICC data mergers, one collecting data on eligible pregnancies with estimated date of delivery prior to 2015, and the second collecting data on eligible pregnancies since 2015 (2020/2021 merger).

You may qualify if:

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

Sponsors & Collaborators

• Fondazione Penta UK: lead
• UCL Great Ormond Street Institute of Child Health: collaborator

Study Sites (10)

Centre Hospitalier Universitaire Saint Pierre

Brussels, Belgium

RECRUITING

Università degli studi di Firenze

Florence, Italy

RECRUITING

"Victor Babes" Hospital

Bucharest, Romania

RECRUITING

State Budgetary Institution of Health Protection Irkutsk

Arkhangelsk, Russia

COMPLETED

St Petersburg Republican Hospital

Saint Petersburg, Russia

COMPLETED

St. Petersburg State Budgetary Health Institution

Saint Petersburg, Russia

COMPLETED

Hospital San Joan de Deu

Barcelona, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

University Hospital Zurich

Zurich, Switzerland

RECRUITING

University College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claire Thorne

  Professor of infectious disease epidemiology

  STUDY CHAIR

Central Study Contacts

Giorgia Dalla Valle

CONTACT

+39 049 821 5447; giorgia.dallavalle@pentafoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: February 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); BE (1); IT (1); CH (1); GB (1); ES (2); RU (3)