Paediatric Studies
- SARS-CoV-2 antibody study (EPPICC-COVID)
The aim of this study is to describe the prevalence and distribution of antibodies to SARS-CoV- 2 in children and adolescents living with HIV in Europe and South Africa. This serves as the first step towards understanding how much of the population is still at risk of COVID-19 infection and therefore the potential risk of future outbreaks.
The study will also assess the factors associated with the presence of SARS-CoV-2 antibodies and how frequent changes in these antibodies occur. Some of the factors will include demographics, antiretroviral treatment, HIV-associated factors or co-morbidities, exposure to household members with COVID-19 and COVID-19 vaccine status.
- Dolutegravir study
The overall aim of this study is to investigate the uptake, effectiveness, and safety of DTG in infants, children and adolescents in “real world” clinical settings across Europe and Thailand. Results will help assess the impact of increased use of dolutegravir-based-regimens (DBRs) to inform future policy and practice by observing the incidence of clinical and laboratory serious adverse events and adverse events and proportion discontinuing, and reasons for discontinuation of DTG.
The study will also explore changes in weight and BMI over time on DBR and compare the effectiveness (virological suppression and virological failure) and change in weight and BMI among children/adolescents on DBR versus a comparable paediatric population on non-DBR regimens.
- TAF study
Safety and effectiveness of tenofovir alafenamide fumarate (TAF) -based therapy in children and adolescents living with HIV in Eastern and Western Europe and Thailand: a European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) study.
This is an observational study collecting real world safety and effectiveness data and uptake rates of TAF-containing regimens in children and adolescents in routine HIV care in Europe, through a two pooled analysis of longitudinal, pseudonymised individual patient clinical and laboratory data from EPPICC dataset.
The study will compare the changes in growth (weight, height and BMI) and incidence of overweight/obesity among children and adolescents living with HIV and treated with TAF as compared to TDF and ABC.
The study will also describe the occurrence of treatment discontinuations and adverse events (in particular lipids, bone and renal toxicity) in children and adolescents living with HIV while on TAF versus TDF and ABC.
Pregnancy Studies
- Cabotegravir study
Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir Long Acting (CAB LA): Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC).
This study will evaluate the use of CAB in pregnant women, describe the maternal characteristics, estimate the frequency of adverse pregnancy-neonatal outcomes and the perinatal transmission rates; assess proportion of viral suppression achievement.
Among women becoming pregnant while receiving CAB containing ARV regimen, initiating CAB containing regimen during pregnancy, or have received one or more CAB LA injection(s) in the 12 months prior to estimated date of conception, to describe maternal characteristics by timing of exposure to CAB in relation to estimated date of conception (e.g. 0-6 and 6-12 months, pre- conception; and by trimester).
The study will also estimate frequency of adverse pregnancy and neonatal outcomes, by timing of exposure to CAB and estimate perinatal transmission rates in mother-infant pairs. The study will finally assess the proportion of women who achieve viral suppression by the end of pregnancy, by trimester of exposure.
- Raltegravir study
Pregnancy and neonatal outcomes following antenatal exposure to raltegravir (RAL): a pooled analysis from the European Pregnancy and Paediatric HIV Cohort Collaboration
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. The study will describe the frequency of adverse birth outcomes in RAL-exposed pregnancies by timing of exposure and 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.
The study will also assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available. Moreover the study will 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.
The EPPICC pregnancy and paediatric studies are funded by ViiV Healthcare and sponsored by Penta.