Clinical trial NCT05751031: Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
Official title: Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
Collaborators: name: UCL Great Ormond Street Institute of Child Health
First posted: 2023-03-02
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patterns of antenatal use
timeFrame: 12 months
measure: Frequency of averse birth outcomes
timeFrame: 12 months
measure: Birth defects per trimester of exposure
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of discontinuation
timeFrame: 12 months
measure: Viral suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint Pierre
city: Firenze
country: Italy
facility: Università degli studi di Firenze
city: Bucharest
country: Romania
facility: "Victor Babes" Hospital
city: Arkhangelsk
country: Russian Federation
facility: State Budgetary Institution of Health Protection Irkutsk
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg Republican Hospital
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Institution
city: Barcelona
country: Spain
facility: Hospital San Joan de Deu
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: Professor of infectious disease epidemiology
name: Claire Thorne
role: STUDY_CHAIR
References: