HIV InfectionsNCT05751031
Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
An observational study of HIV Infections, run by Fondazione Penta UK at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir
- How many people
- 1,200 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 20 Feb 2023to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- pregnant women living with HIV, exposed to Raltegravir at any time during the pregnancy participating in EPPICC and their infants.
Who cannot join
- see inclusion
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Russia3 sites
- Completed
State Budgetary Institution of Health Protection Irkutsk
Arkhangelsk
- Completed
St Petersburg Republican Hospital
Saint Petersburg
- Completed
St. Petersburg State Budgetary Health Institution
Saint Petersburg
Spain2 sites, 2 recruiting
- Recruiting
Hospital San Joan de Deu
Barcelona
Claudia Fortuny Guasch, Cfortuny@sjdhospitalbarcelona.org
- Recruiting
Hospital Clinico San Carlos
Madrid
Luis Prieto Tato
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Saint Pierre
Brussels
Philippe Leroy, philippe.leroy@stpierre-bru.be
Italy1 site, 1 recruiting
- Recruiting
Università degli studi di Firenze
Florence
Luisa Galli
Romania1 site, 1 recruiting
- Recruiting
"Victor Babes" Hospital
Bucharest
Luminita Ene
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Christian Kahlert
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London
Claire Thorne
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Raltegravir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Raltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Frequency of discontinuation
To assess the frequency of discontinuation of RAL during pregnancy and potential reasons where data are available.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Penta UK
- Sponsor type
- Research network
- Collaborators
- UCL Great Ormond Street Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Claire Thorne, Study chair, Professor of infectious disease epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751031
- Sponsor's protocol ID
- Raltegravir
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
- ClinicalTrials.gov ID
- NCT05751031
- Acronym / sponsor ID
- Raltegravir
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondazione Penta UKResearch network
- Collaborators
- UCL Great Ormond Street Institute of Child Health
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) | – | Drug: RaltegravirPregnant women living with HIV and their infants from 9 European cohorts and studies within the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- pregnant women living with HIV, exposed to Raltegravir at any time during the pregnancy participating in EPPICC and their infants.
Key exclusion criteria (1 listed)
- see inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirRaltegravir exposure in pregnant women living with HIV in routine clinical care. No study intervention administrated. | Drug | European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) |
Primary outcome
Patterns of antenatal use
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Frequency of discontinuation
Time frame: 12 months
Viral suppression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Thorne study chair
Professor of infectious disease epidemiology
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Fondazione Penta UK at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia, Spain, Belgium, Italy, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgia Dalla Valle (+39 049 821 5447, giorgia.dallavalle@pentafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of antenatal use (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.