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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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Centre Hospitalier Universitaire Saint Pierre
Brussels, Belgium
Università degli studi di Firenze
Florence, Italy
"Victor Babes" Hospital
Bucharest, Romania
State Budgetary Institution of Health Protection Irkutsk
Arkhangelsk, Russia
St Petersburg Republican Hospital
Saint Petersburg, Russia
St. Petersburg State Budgetary Health Institution
Saint Petersburg, Russia
Hospital San Joan de Deu
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
University Hospital Zurich
Zurich, Switzerland
University College London
London, United Kingdom
Start Date
February 20, 2023
Primary Completion Date
February 20, 2024
Completion Date
February 20, 2024
Last Updated
March 2, 2023
1,200
ESTIMATED participants
Raltegravir
DRUG
Lead Sponsor
Fondazione Penta UK
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330