HIV InfectionVIROPREGNCT07412977
"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort"
An observational study of HIV Infection and HBV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infection, HBV Infection, HDV Infection
- What is being tested?
- Blood sampling, Umbilical cord blood sampling and Survey using a questionnaire
- How many people
- 5,160 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Dec 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women living with either HIV and/or HBV and/or HCV and/or Arbovirus will be enrolled in the study. After delivery, their child/children will also be enrolled.
Who may be able to join
- Pregnant women :
- Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);
- Age ≥18 years;
- Viral infection studied known before pregnancy or diagnosed during pregnancy;
- Signed, free, informed and written consent;
- Be cared for in one of the maternity units taking part in the study
- Newborns/children:
- Free, informed, written and signed consent of parental guardians.
Who cannot join
- Pregnant women :
- Planned delivery in a non-study center;
- Planned absence that could hinder participation in the research;
- Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);
- Level of French oral comprehension insufficient according to the investigator for the research process understanding
- Newborns/children:
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- Refusal of parental authority to allow newborn/child to participate in study
- Follow-up of the child planned in a center not participating in the study
- Scheduled absence of parents that could hinder the child's participation in the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre de Méthodologie et de Gestion de Bichat
Paris, 75018
Project Manager, 01 40 25 70 41, viropreg.anrs@inserm.fr
About this study
Official title: "Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."
The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)] and on arbovirus infections.
This study aims at investigating the following research questions:
Read more
- What is the rate of mother-to-child transmission for each virus?
- What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?
- What is the impact of antiretroviral and/or antiviral prophylactic and/or therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.
HIV Cohort:
Pregnant women living with HIV who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)
- Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes
- Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum
- In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.
- In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).
Children born to mothers living with HIV and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age
- Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
HBV Cohort:
Pregnant HBV-infected women who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)
- Complete questionnaires at inclusion and delivery
- Provide blood samples during follow-up visits for research purposes.
Children born to HBV-infected mothers and who participate in the research will:
- Be followed according to the routine care schedule from birth to 2 years of age
- Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.
HCV Cohort:
Pregnant HCV-infected women who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)
- Complete questionnaires at inclusion and delivery
- Provide blood samples during follow-up visits for research purposes.
Children born to HCV-infected mothers and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age
- Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.
Arbovirus Cohort:
Pregnant women infected with arbovirus who participate in the research will:
- Be followed according to the routine care schedule from enrollment to delivery
- Participate in additional follow-up for research purposes at 4 years after delivery.
- In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum
- Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery
- Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.
Children born to mothers infected with arbovirus and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age.
- Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion
- Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
- Conditions
- HIV Infection, HBV Infection, HDV Infection, HCV Infection, Arbovirus Infections
- Being tested
- Blood sampling, Umbilical cord blood sampling, Survey using a questionnaire, Breast milk sampling, Amniotic fluid sampling
- Keywords
- Pregnancy, HIV, HBV, HCV, Arbovirus, National health data system, Neurocognitive disorders, Quality of life, Pregnancy viral infections, Mother-to-child transmission, Social epidemiology, Hepatitis
- Medical subject headings
- HIV Infections, Hepatitis C, Arbovirus Infections, Neurocognitive Disorders, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling will be done to perform pharmacological and virological analysis.
Umbilical cord blood samplingBiological
Umbilical cord blood will be sampled to perform pharmacological analysis.
Survey using a questionnaireOther
Questionnaires will be administered to the participant at different times during the study.
Breast milk samplingBiological
If breastfeeding, breast milk will be collected to perform pharmacological analysis.
Amniotic fluid samplingBiological
Amniotic fluid will be sampled for virological and immunological analysis and biobanquing
Urine samplingBiological
Urine will be sampled for biobanquing
Vaginal swabBiological
Vaginal swab will be sampled for biobanquing
Placenta samplingBiological
Placenta will be sampled for virological and immunological analysis
| Study group | Role | What they receive |
|---|---|---|
| HIV-1/HIV-2 Cohort | If they consent, pregnant women living with HIV-1 or HIV-2 will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active and passive follow-up until the age of 7 years old. Receives: Biological: Blood sampling; Biological: Umbilical cord blood sampling; Other: Survey using a questionnaire; Biological: Breast milk sampling | |
| HBV Cohort | If they consent, pregnant women living with HBV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. Receives: Biological: Blood sampling; Other: Survey using a questionnaire | |
| HCV Cohort | If they consent, pregnant women living with HCV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. Receives: Biological: Blood sampling; Other: Survey using a questionnaire | |
| Arbovirus Cohort | If they consent, pregnant women with symptomatic, biologically confirmed arbovirus infection, will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. Receives: Biological: Blood sampling; Biological: Umbilical cord blood sampling; Other: Survey using a questionnaire; Biological: Breast milk sampling; Biological: Amniotic fluid sampling; Biological: Urine sampling; Biological: Vaginal swab; Biological: Placenta sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age
Measured: From enrollment to the end of follow-up at the age of 4
Hepatitis B Cohort: HBV infection at 9 months of age
Measured: From enrollment of the child to 9 months of age
Hepatitis C Cohort: HCV infection between 18 and 24 months of age
Measured: From enrollment of the child to between 18 and 24 months of age
Arbovirus Cohort: For each arbovirus, occurrence of one of the following events defining an unfavourable pregnancy outcome, from among: o Maternal/fetal: spontaneous miscarriage, fetal death in utero, medical abortion; o Neonatal: neonatal death
Measured: From enrollment up to 28 days of newborn's life
Secondary outcomes (63)
HIV-1/HIV-2 cohort :The impact of exposure to HIV-1/HIV-2 and antiretroviral treatment in children born to mothers living with HIV-1/HIV-2
The impact of exposure to HIV-1/HIV-2 and antiretroviral treatment will be assessed on:
- Presence of major congenital malformations
- HIV-1/HIV-2 infection in children
- Autism spectrum disorders between 18 and 24 months old, as measured by the Modified Checklist Autism for Toddlers (M-CHAT)
- Growth parameters (weight, height, head circumference) from birth to 2 years old;
- Learning and coordination disorders, hyperactivity (ADHD), autistic traits assessed at 7 years old by the "Autism-Tics, ADHD and other Comorbidities" (A-TAC) questionnaire;
- Hospitalizations, late-onset congenital malformations (cardiac or cerebral) and chronic illnesses occurring during the child's first 7 years of life, identified using data from:PMSI, DCIR
- Death at age 7
Measured: From enrollement of children to the age of 7 years old
HIV-1/HIV-2 cohort : Social determinants in children born to mothers living with HIV-1/HIV-2
Social determinants will be collected with the social deprivation during pregnancy index (SDI). The contribution of social determinants will be assessed on the health and development indicators at 4 and 7 years old
Measured: From enrollment of the children to the age of 7 years old
HIV-1/HIV-2 cohort : Post-natal antiretroviral prophylaxis in children born to mothers living with HIV-1/HIV-2
Measured: From enrollement of children to the age of 2 years old
HIV-1/HIV-2 Cohort: Obstetrical pathologies, hospitalizations and adverse pregnancy outcomes in pregnant women living with HIV-1/HIV-2
Measured: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Social determinants in pregnant women living with HIV-1/HIV-2
Social determinants will be collected using the SDI and the augmented PRECAR score.
Measured: From enrollment of pregnant women up to the children's 7 years old
HIV-1/HIV-2 Cohort: Obstetrical management during pregnancy, including obstetrical follow-up, invasive procedures during pregnancy (trophoblast biopsy, amniocentesis) and decisions concerning the delivery method in pregnant women living with HIV-1/HIV-2
Measured: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort:Therapeutic sequences,viral load and CD4 count during pregnancy and at delivery; clinical and biological tolerance of treatments;plasma ARV assays;ARV resistance genotypes performed in routine in pregnant women living with HIV-1/HIV-2
Measured: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Quality of life in pregnant women living with HIV-1/HIV-2
Quality of life will be assessed by the WHOQOL-BREF during the delivery stay
Measured: Delivery stay
HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2
Adherence of women will be assessed through HIV-related literacy with the FCCHL (Functional, Communicative and Critical Health Literacy scale) during the delivery stay.
Measured: Delivery stay
HIV-1/HIV-2 Cohort: Experienced discrimination and care-giver interactions in pregnant women living with HIV-1/HIV-2
Measured: During the delivery stay and during the telephone visit at child's 4 years old
HIV-1/HIV-2 Cohort: Sharing of virological status in pregnant women living with HIV-1/HIV-2
Measured: During the delivery stay and during the telephone visit at child's 4 years of age
HIV-1/HIV-2 Cohort: Presence of anxiety-depressive symptoms in pregnant women living with HIV-1/HIV-2
Presence of anxiety-depressive symptoms using the EPDS questionnaire
Measured: Delivery stay
HIV-1/HIV-2 Cohort: Non-optimal access to care during pregnancy; comparison of care consumption with HAS recommendations for pregnancy monitoring
Measured: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Breast-feeding practices: in the event of breast-feeding
Measured: During the breast-feeding period, up to 24 months after delivery
HIV-1/HIV-2 Cohort: Measurement of drug concentration in plasma in pregnant women treated with certains targeted drugs
Targeted drugs are: tenofovir alafenamide, etravirine, doravirine, rilpivirine, bictegravir,dolutegravir, cabotegravir, raltegravir, fostemsavir, lenacapavir, any new ARV not yet marketed in 2023 (islatravir, ibalizumab...)
Measured: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Monthly measurements of ARV drug concentration in breast milk (if breast-feeding)
Measured: During the breast-feeding
HIV-1/HIV-2 Cohort: In breast-fed newborns, monthly measurements of plasma concentrations of the same ARVs
Measured: During the breast-feeding
HBV Cohort: Delay between diagnosis of HBV infection and date of onset of pregnancy in HBV-infected pregnant women
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Therapeutic prophylaxis practices in HBV-infected pregnant women
Measured: From enrollment of pregnant women to delivery
HBV Cohort: HBV viral load during obstetrical follow-up and at delivery in HBV-infected pregnant women
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Plasma concentrations of HBV antivirals in treated women
Measured: At inclusion and at delivery
HBV Cohort: Maternal morbidity and mortality
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Initiation or resumption of follow-up by a hepatologist of postpartum HBV-infected women
Measured: During the post-partum period, up to 2 months after delivery
HBV Cohort: Screening practices among close contacts of infected women
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Seroprevalence of HDV in HBV-infected pregnant women
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Active HDV infection (in women with positive HDV serology)
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Liver disease at fibrosis, cirrhosis and/or hepatic carcinoma stage during pregnancy in HBV-infected pregnant women (+/- HDV)
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Social determinants in HBV-infected pregnant women
Social determinants will be assessed by the social deprivation during pregnancy index (SDI) and the augmented PRECAR score
Measured: At inclusion and during the delivery stay
HBV Cohort: Adherence of HBV-infected pregnant women
Measured: During the delivery stay
HBV Cohort: Presence of anxiety-depressive symptoms in women living with HBV
Measured: During the delivery stay
HBV Cohort: Experienced discrimination and care-giver interactions in HBV-infected pregnant women
Measured: During the delivery stay
HBV Cohort: Non-optimal access to healthcare during pregnancy; study of healthcare consumption in relation to HAS recommendations for pregnancy monitoring
Measured: From enrollment of pregnant women to delivery
HBV Cohort: Post-natal serovaccination of children and schedule
Measured: From enrollement of children to the age of 2 years old
HBV Cohort: HBV infection in children born to HBV-infected mothers
Measured: From birth to the age of 2 years old
HBV Cohort: Factors associated to mother-to-child transmission of HBV (maternal antiviral prophylaxis, neonatal serotherapy, vaccination, hepatitis B profile, level of viral replication, social determinants)
Measured: During the follow-up period, up to 2 months after delivery
HBV Cohort: Timing of mother-to-child transmission in HBV-infected children
Measured: 9 months after delivery
HBV Cohort: Hospitalizations and chronic illnesses
Measured: From enrollement of children to the age of 7 years old
HBV Cohort: HDV infection in children born to mother co-infected with HBV/HDV
Measured: 9 months after delivery
HCV Cohort: Socio-demographic profile of infected women
Measured: At inclusion
HCV Cohort: Maternal morbidity and mortality events in HCV-infected pregnant women
Measured: From enrollment of pregnant women to delivery
HCV Cohort: Management practices during pregnancy (treatment, date of initiation, dosage, duration of treatment, date of end of treatment and reason for discontinuation, if applicable); and post-partum (follow-up by an hepatologist)
Measured: From enrollment of pregnant women up to 2 months after delivery
HCV Cohort: Liver disease at fibrosis, cirrhosis and/or hepatocellular carcinoma stage during pregnancy in HCV-infected women
Measured: From enrollment of pregnant women to delivery
HCV Cohort: Initiation or resumption of post-partum follow-up by a hepatologist for women infected with HCV during pregnancy
Measured: During the post-partum period, up to 2 months after delivery
HCV Cohort: HCV antiviral treatment during pregnancy
Measured: From enrollment of pregnant women to delivery
HCV Cohort: Plasma concentrations of antivirals during pregnancy in women receiving HCV treatment
Measured: From enrollment of pregnant women to delivery
HCV Cohort: Adherence of HCV-infected pregnant women
Measured: During the delivery stay
HCV Cohort: Presence of anxiety-depressive symptoms in women living with HCV
Measured: During the delivery stay
HCV Cohort: Active HCV infection in children born to HCV-infected mothers
Measured: At 3 months of age
HCV Cohort: Diagnostic performance of PCR at 3 months between 18 and 24 months of age
Measured: At child's 3months and 18-24 months
HCV Cohort: Spontaneous cure rate at 9 months and between 18 and 24 months of age
Measured: At child's 9 months and 18-24 months
HCV Cohort: Morbidity criteria in the first 7 years of life
Measured: From enrollement of children to the age of 7 years old
Arbovirosis Cohort: Occurrence of obstetrical pathologies, hospitalisations/stays in intensive care during pregnancy, other unfavourable pregnancy outcomes (premature delivery, etc.), or maternal death
Measured: From enrollment of pregnant women to delivery
Arbovirosis Cohort: Demographic, clinical, biological, virological, immunological and genetic factors associated with, or predictive of, the occurrence of a severe course (shock, haemorrhage, visceral failure, death) of arbovirosis during pregnancy
Measured: From enrollment of pregnant women to delivery
Arbovirosis Cohort: Quality of life in pregnant women with symptomatic, virologically confirmed arbovirus infection
Quality of life will be assessed by the EuroQol-5 Dimension (EQ5D) and by the WHOQOL-BREF
Measured: At day 1 and between day7-10 post-infection and during the delivery stay
Arbovirosis Cohort: Effect of social determinants on the occurrence of obstetrical pathologies, hospitalisations/stays in intensive care unit during pregnancy, other adverse pregnancy outcomes (premature delivery, etc.) or maternal death
Measured: At inclusion, at 4 years post-delivery and during the delivery stay
Arbovirosis Cohort: Detection of viral RNA by qualitative or semi-quantitative PCR in the placenta and amniotic fluid
Measured: At delivery
Arbovirosis Cohort: Detection of viral RNA by qualitative or semi-quantitative PCR in breast milk in breast-feeding women with history of symptomatic, virologically confirmed arbovirus infection during pregnancy,
Measured: At day 1, day 7 and day 30 after delivery
Arbovirosis Cohort: Prevalence of major congenital malformations; Arbovirus infection; Autism spectrum disorders;Confirmed arbovirus infection/hospitalization related to maternal/infant arbovirosis;Disorders; hospitalizations, chronic illness, death
The prevalence will be estimated for:
- Major congenital malformations according to the EUROCAT classification diagnosed in the first 3 months of life;
- Arbovirus infection confirmed at birth defined by detection of arbovirus by PCR in blood at birth;
- Autism spectrum disorders at 18-24 months of age, evaluated by using the Modified Checklist Autism for Toddlers (M-CHAT);
- Confirmed arbovirus infection and/or hospitalization related to maternal and/or infant arbovirosis during the first 24 months of life;
- Disorders of (i) the gross and fine motor skills, assessed by using the "little Developmental Coordination Disorder Questionnaire-French European" (little DCDQ-FE) and (ii) the socioemotional development assessed by using the "Strengths \& Difficulties questionnaire" (SDQ) at 4 years of age.
- Hospitalizations, late-onset congenital malformations (cardiac or cerebral), chronic illnesses and death occurring during the child's first 7 years of life, identified using data from PMSI
Measured: From enrollement of children to the age of 7 years old
Arbovirosis Cohort: Clinical progression of the disease in infected children diagnosed with an arbovirus infection at birth,
Clinical progression of the disease will be characterised by symptoms, their severity and duration
Measured: First 30 days of children life
Arbovirosis Cohort: Plasma viremia progression in infected children diagnosed with an arbovirus infection at birth
Plasma viremia progression will be measured by specific RT-PCR
Measured: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Presence of total and neutralising antibodies against the arbovirus in the blood, in infected children diagnosed with an arbovirus infection at birth
Measured: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Presence of total and neutralising antibodies against the arbovirus in the blood in breast-fed children not infected at birth
Measured: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Confirmed arbovirus infection in breast-fed children not infected at birth
Confirmed arbovirus infection will be defined by detection of arbovirus by PCR in blood
Measured: During breastfeeding, at day 7 and day 30 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- 5,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412977
- Sponsor's protocol ID
- ANRS0288s VIROPREG
- Acronym
- VIROPREG
- Status last verified
- Feb 2026
- First submitted
- 8 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."
- ClinicalTrials.gov ID
- NCT07412977
- Acronym / sponsor ID
- VIROPREG / ANRS0288s VIROPREG
- Conditions
- HIV Infection, HBV Infection, HDV Infection, HCV Infection, Arbovirus Infections
- Keywords
- Pregnancy, HIV, HBV, HCV, Arbovirus, National health data system, Neurocognitive disorders, Quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,160 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 17 Feb 2026 (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.
The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)] and on arbovirus infections.
This study aims at investigating the following research questions:
- What is the rate of mother-to-child transmission for each virus?
- What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?
- What is the impact of antiretroviral and/or antiviral prophylactic and/or therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.
HIV Cohort:
Pregnant women living with HIV who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)
- Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes
- Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum
- In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.
- In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).
Children born to mothers living with HIV and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age
- Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
HBV Cohort:
Pregnant HBV-infected women who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)
- Complete questionnaires at inclusion and delivery
- Provide blood samples during follow-up visits for research purposes.
Children born to HBV-infected mothers and who participate in the research will:
- Be followed according to the routine care schedule from birth to 2 years of age
- Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.
HCV Cohort:
Pregnant HCV-infected women who participate in the research will:
- Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)
- Complete questionnaires at inclusion and delivery
- Provide blood samples during follow-up visits for research purposes.
Children born to HCV-infected mothers and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age
- Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.
Arbovirus Cohort:
Pregnant women infected with arbovirus who participate in the research will:
- Be followed according to the routine care schedule from enrollment to delivery
- Participate in additional follow-up for research purposes at 4 years after delivery.
- In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum
- Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery
- Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.
Children born to mothers infected with arbovirus and who participate in the research will:
- Be followed according to the routine care schedule from birth until 2 years of age.
- Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion
- Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV-1/HIV-2 Cohort | – | Biological: Blood sampling, Biological: Umbilical cord blood sampling, Other: Survey using a questionnaire, Biological: Breast milk samplingIf they consent, pregnant women living with HIV-1 or HIV-2 will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active and passive follow-up until the age of 7 years old. |
| HBV Cohort | – | Biological: Blood sampling, Other: Survey using a questionnaireIf they consent, pregnant women living with HBV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. |
| HCV Cohort | – | Biological: Blood sampling, Other: Survey using a questionnaireIf they consent, pregnant women living with HCV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. |
| Arbovirus Cohort | – | Biological: Blood sampling, Biological: Umbilical cord blood sampling, Other: Survey using a questionnaire, Biological: Breast milk sampling, Biological: Amniotic fluid sampling, Biological: Urine sampling, Biological: Vaginal swab, Biological: Placenta samplingIf they consent, pregnant women with symptomatic, biologically confirmed arbovirus infection, will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women living with either HIV and/or HBV and/or HCV and/or Arbovirus will be enrolled in the study. After delivery, their child/children will also be enrolled.
Key inclusion criteria (8 listed)
- Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);
- Age ≥18 years;
- Viral infection studied known before pregnancy or diagnosed during pregnancy;
- Signed, free, informed and written consent;
- Be cared for in one of the maternity units taking part in the study
Key exclusion criteria (9 listed)
- Planned delivery in a non-study center;
- Planned absence that could hinder participation in the research;
- Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);
- Level of French oral comprehension insufficient according to the investigator for the research process understanding
- Refusal of parental authority to allow newborn/child to participate in study
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 |
|---|---|---|
| Blood samplingBlood sampling will be done to perform pharmacological and virological analysis. | Biological | Arbovirus Cohort, HBV Cohort, HCV Cohort, HIV-1/HIV-2 Cohort |
| Umbilical cord blood samplingUmbilical cord blood will be sampled to perform pharmacological analysis. | Biological | Arbovirus Cohort, HIV-1/HIV-2 Cohort |
| Survey using a questionnaireQuestionnaires will be administered to the participant at different times during the study. | Other | Arbovirus Cohort, HBV Cohort, HCV Cohort, HIV-1/HIV-2 Cohort |
| Breast milk samplingIf breastfeeding, breast milk will be collected to perform pharmacological analysis. | Biological | Arbovirus Cohort, HIV-1/HIV-2 Cohort |
| Amniotic fluid samplingAmniotic fluid will be sampled for virological and immunological analysis and biobanquing | Biological | Arbovirus Cohort |
| Urine samplingUrine will be sampled for biobanquing | Biological | Arbovirus Cohort |
| Vaginal swabVaginal swab will be sampled for biobanquing | Biological | Arbovirus Cohort |
| Placenta samplingPlacenta will be sampled for virological and immunological analysis | Biological | Arbovirus Cohort |
Primary outcome
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age
Time frame: From enrollment to the end of follow-up at the age of 4
Hepatitis B Cohort: HBV infection at 9 months of age
Time frame: From enrollment of the child to 9 months of age
Hepatitis C Cohort: HCV infection between 18 and 24 months of age
Time frame: From enrollment of the child to between 18 and 24 months of age
Arbovirus Cohort: For each arbovirus, occurrence of one of the following events defining an unfavourable pregnancy outcome, from among: o Maternal/fetal: spontaneous miscarriage, fetal death in utero, medical abortion; o Neonatal: neonatal death
Time frame: From enrollment up to 28 days of newborn's life
63 secondary outcomes
HIV-1/HIV-2 cohort :The impact of exposure to HIV-1/HIV-2 and antiretroviral treatment in children born to mothers living with HIV-1/HIV-2
Time frame: From enrollement of children to the age of 7 years old
HIV-1/HIV-2 cohort : Social determinants in children born to mothers living with HIV-1/HIV-2
Time frame: From enrollment of the children to the age of 7 years old
HIV-1/HIV-2 cohort : Post-natal antiretroviral prophylaxis in children born to mothers living with HIV-1/HIV-2
Time frame: From enrollement of children to the age of 2 years old
HIV-1/HIV-2 Cohort: Obstetrical pathologies, hospitalizations and adverse pregnancy outcomes in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Social determinants in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women up to the children's 7 years old
HIV-1/HIV-2 Cohort: Obstetrical management during pregnancy, including obstetrical follow-up, invasive procedures during pregnancy (trophoblast biopsy, amniocentesis) and decisions concerning the delivery method in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort:Therapeutic sequences,viral load and CD4 count during pregnancy and at delivery; clinical and biological tolerance of treatments;plasma ARV assays;ARV resistance genotypes performed in routine in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Quality of life in pregnant women living with HIV-1/HIV-2
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Experienced discrimination and care-giver interactions in pregnant women living with HIV-1/HIV-2
Time frame: During the delivery stay and during the telephone visit at child's 4 years old
HIV-1/HIV-2 Cohort: Sharing of virological status in pregnant women living with HIV-1/HIV-2
Time frame: During the delivery stay and during the telephone visit at child's 4 years of age
HIV-1/HIV-2 Cohort: Presence of anxiety-depressive symptoms in pregnant women living with HIV-1/HIV-2
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Non-optimal access to care during pregnancy; comparison of care consumption with HAS recommendations for pregnancy monitoring
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Breast-feeding practices: in the event of breast-feeding
Time frame: During the breast-feeding period, up to 24 months after delivery
HIV-1/HIV-2 Cohort: Measurement of drug concentration in plasma in pregnant women treated with certains targeted drugs
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Monthly measurements of ARV drug concentration in breast milk (if breast-feeding)
Time frame: During the breast-feeding
HIV-1/HIV-2 Cohort: In breast-fed newborns, monthly measurements of plasma concentrations of the same ARVs
Time frame: During the breast-feeding
HBV Cohort: Delay between diagnosis of HBV infection and date of onset of pregnancy in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Therapeutic prophylaxis practices in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: HBV viral load during obstetrical follow-up and at delivery in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Plasma concentrations of HBV antivirals in treated women
Time frame: At inclusion and at delivery
HBV Cohort: Maternal morbidity and mortality
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Initiation or resumption of follow-up by a hepatologist of postpartum HBV-infected women
Time frame: During the post-partum period, up to 2 months after delivery
HBV Cohort: Screening practices among close contacts of infected women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Seroprevalence of HDV in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Active HDV infection (in women with positive HDV serology)
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Liver disease at fibrosis, cirrhosis and/or hepatic carcinoma stage during pregnancy in HBV-infected pregnant women (+/- HDV)
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Social determinants in HBV-infected pregnant women
Time frame: At inclusion and during the delivery stay
HBV Cohort: Adherence of HBV-infected pregnant women
Time frame: During the delivery stay
HBV Cohort: Presence of anxiety-depressive symptoms in women living with HBV
Time frame: During the delivery stay
HBV Cohort: Experienced discrimination and care-giver interactions in HBV-infected pregnant women
Time frame: During the delivery stay
HBV Cohort: Non-optimal access to healthcare during pregnancy; study of healthcare consumption in relation to HAS recommendations for pregnancy monitoring
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Post-natal serovaccination of children and schedule
Time frame: From enrollement of children to the age of 2 years old
HBV Cohort: HBV infection in children born to HBV-infected mothers
Time frame: From birth to the age of 2 years old
HBV Cohort: Factors associated to mother-to-child transmission of HBV (maternal antiviral prophylaxis, neonatal serotherapy, vaccination, hepatitis B profile, level of viral replication, social determinants)
Time frame: During the follow-up period, up to 2 months after delivery
HBV Cohort: Timing of mother-to-child transmission in HBV-infected children
Time frame: 9 months after delivery
HBV Cohort: Hospitalizations and chronic illnesses
Time frame: From enrollement of children to the age of 7 years old
HBV Cohort: HDV infection in children born to mother co-infected with HBV/HDV
Time frame: 9 months after delivery
HCV Cohort: Socio-demographic profile of infected women
Time frame: At inclusion
HCV Cohort: Maternal morbidity and mortality events in HCV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and HBV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age (time frame: From enrollment to the end of follow-up at the age of 4). The study lists 4 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 17 Feb 2026.