HIV Infections
Conditions
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.
Interventions
DRUGRaltegravir
Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated.
Sponsors
UCL Great Ormond Street Institute of Child Health
Fondazione Penta UK
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium, Italy, Romania, Russia, Spain, Switzerland, United Kingdom
Contacts
Primary ContactGiorgia Dalla Valle
Outcome results
None listed