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

Study Overview
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)<br>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<br>* Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of discontinuation | To assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available. | 12 months | 
| 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 |