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| Name | Class |
|---|---|
| UCL Great Ormond Street Institute of Child Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgia Dalla Valle | Contact | +39 049 821 5447 | giorgia.dallavalle@pentafoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Claire Thorne | Professor of infectious disease epidemiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Saint Pierre | Recruiting | Brussels | Belgium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 15, 2024 | |
| Reset | Oct 10, 2024 |
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| 12 months |
| Università degli studi di Firenze | Recruiting | Florence | Italy |
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| "Victor Babes" Hospital | Recruiting | Bucharest | Romania |
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| State Budgetary Institution of Health Protection Irkutsk | Completed | Arkhangelsk | Russia |
| St Petersburg Republican Hospital | Completed | Saint Petersburg | Russia |
| St. Petersburg State Budgetary Health Institution | Completed | Saint Petersburg | Russia |
| Hospital San Joan de Deu | Recruiting | Barcelona | Spain |
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| Hospital Clinico San Carlos | Recruiting | Madrid | Spain |
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| University Hospital Zurich | Recruiting | Zurich | Switzerland |
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| University College London | Recruiting | London | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 15, 2024 | Oct 10, 2024 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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