Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated.
|
Outcome Measures
Primary Outcome Measures
- Patterns of antenatal use [12 months]
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
- Frequency of averse birth outcomes [12 months]
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
- Birth defects per trimester of exposure [12 months]
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
Secondary Outcome Measures
- Frequency of discontinuation [12 months]
To assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available.
- Viral suppression [12 months]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire Saint Pierre | Brussels | Belgium | ||
| 2 | Università degli studi di Firenze | Firenze | Italy | ||
| 3 | "Victor Babes" Hospital | Bucharest | Romania | ||
| 4 | State Budgetary Institution of Health Protection Irkutsk | Arkhangelsk | Russian Federation | ||
| 5 | St Petersburg Republican Hospital | Saint Petersburg | Russian Federation | ||
| 6 | St. Petersburg State Budgetary Health Institution | Saint Petersburg | Russian Federation | ||
| 7 | Hospital San Joan de Deu | Barcelona | Spain | ||
| 8 | Hospital Clinico San Carlos | Madrid | Spain | ||
| 9 | University Hospital Zurich | Zürich | Switzerland | ||
| 10 | University College London | London | United Kingdom |
Sponsors and Collaborators
- Fondazione Penta UK
- UCL Great Ormond Street Institute of Child Health
Investigators
- Study Chair: Claire Thorne, Professor of infectious disease epidemiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Raltegravir