Virus-HIVENIVIHNCT06666543
Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital
An observational study of Virus-HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"The strategies for the Prevention of Mother-to-Child Transmission of the Human Immunodeficiency Virus (HIV) are very effective and have become common practices in many contexts. Some studies have identified clinical and biological anomalies in a small proportion of infants exposed to antiretrovirals. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Virus-HIV
- What is being tested?
- Questionary
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2024to 1 Jun 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: woman followed in the SMIT of Bichat-Claude Bernard Hospital, who gave birth at the maternity ward of this hospital between 01/01/2007 and 31/12/2022 to a child who is HIV-uninfected
Who may be able to join
None listed.
Who cannot join
- Refusal to participate in the study
- Not speaking French"
Trial locations and contacts
1 site in 1 country.
About this study
"The strategies for the Prevention of Mother-to-Child Transmission of the Human Immunodeficiency Virus (HIV) are very effective and have become common practices in many contexts.
Some studies have identified clinical and biological anomalies in a small proportion of infants exposed to antiretrovirals. Beyond 2 years of age, there are few studies with low power describing the long-term consequences of perinatal exposure to antiretrovirals.
Read more
It is necessary to understand the impact of antiretroviral treatment during the perinatal period in order to improve the management of children born to HIV-positive mothers.
Retrospective cohort study with interviews of women living with HIV who were followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France.
After recruitment during a follow-up consultation:
- Information regarding the prenatal and perinatal management of HIV and the infant's outcomes up to 12 months will be collected retrospectively through the medical record
- Information regarding the child's development and follow-up from the age of 1 to a maximum of 15 years will be gathered retrospectively through a self-administered questionnaire or a questionnaire filled out with assistance during a single 1-hour interview with the mother."
Read the detailed description
The latest WHO report shows that with 1.3 million (between 970,000 and 1.6 million) HIV-positive pregnant women worldwide in 2020, HIV remains a major global public health issue.
In France, about 2 per 1,000 pregnant women are infected with HIV, resulting in approximately 1,500 births per year over the past fifteen years. The administration of antiretroviral treatment to HIV-positive pregnant women and prophylaxis for infants immediately after birth is the most effective means of preventing mother-to-child transmission (MTCT) of HIV. This risk has been estimated at 0.2% during the period from 2011 to 2017 among women included in the French perinatal survey.
While the number of children infected with HIV is decreasing due to wider access to antiretroviral treatments during pregnancy, the number of HIV-exposed but uninfected children is increasing, raising questions about their long-term outcomes.
Some historical studies have identified clinical and biological anomalies, including lactic acidosis, cardiomyopathy, and neurological anomalies, suggesting mitochondrial dysfunction in a small proportion of uninfected children exposed to antiretrovirals.
Since then, recent studies have provided new evidence suggesting that HIV-exposed but uninfected children, while avoiding vertical transmission of HIV, are at a higher risk of suboptimal health outcomes, including higher rates of severe infectious morbidity, lower early childhood survival, and more frequent occurrences of growth delay and neurological development issues compared to children born without HIV exposure.
Additionally, concerns have been raised about neural tube closure anomalies in children exposed to efavirenz and dolutegravir at the time of conception. However, recent data showed that the prevalence of neural tube closure anomalies did not differ significantly between dolutegravir and other antiretrovirals since conception.
Nonetheless, some studies have acknowledged methodological weaknesses, indicating that further research is needed to evaluate each medication individually and how antiretroviral treatment regimens affect the outcomes of infants during the perinatal period.
Consensus guidelines recommend follow-up for HIV-exposed but uninfected children up to 24 months of age. Currently, there is no active long-term follow-up program in France for asymptomatic children. Follow-up may be extended if the child presents a clinical or biological anomaly. Families should be informed of the importance of reporting significant clinical events to their healthcare provider and/or the center that monitored the child in the early months of life. The healthcare provider managing the mother may also play a role in the long-term screening of significant clinical events in the child by gathering information from the mother he or she follows.
Beyond 2 years of age, there are few studies with low power describing the long-term consequences of in utero or perinatal exposure to antiretrovirals.
The participation of children and their parents in observational studies is essential for research, necessary to monitor and identify long-term health outcomes following perinatal exposure to HIV and antiretrovirals.
The objective of this retrospective study is to describe the outcomes of HIV-exposed but uninfected children born to HIV-positive mothers followed at Bichat-Claude Bernard Hospital
- Conditions
- Virus-HIV
- Being tested
- Questionary
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaryOther
The questionnaire will address the following topics for each child who is not infected with HIV and was born to an infected mother at the time of birth:
- Pregnancy progression
- Immediate postpartum course
- Medical development of the child from 0 to 3 years
- Medical development of the child from 3 to a maximum of 15 years
| Study group | Role | What they receive |
|---|---|---|
| Women Living with HIV | Women Living with HIV Who Have Given Birth to HIV-Exposed, Uninfected Children Receives: Other: Questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years)
Clinical events of interest will be collected through a survey from the mother (Eye disorders, Developmental disorders, Language disorders, Hearing disorders, Bone and joint disorders, Cardiac anomalies, Metabolic anomalies (Diabetes, Thyroid, etc.), Pulmonary anomalies, Urinary anomalies, Renal anomalies, Hematological anomalies (sickle cell disease, anemia, etc.))
Measured: 1 day
Secondary outcomes (7)
Describe the course of the pregnancy
Measured: at inclusion
Describe the course of the immediate postpartum period
Measured: at inclusion
Describe the medical follow-up of children between 0 and 3 years old
Measured: at inclusion
Describe the medical follow-up of children between 3 and 15 years old
Measured: at inclusion
Describe the events that occurred in children by age group
events are :Eye disorders, Developmental disorders, Language disorders, Hearing disorders, Bone and joint disorders, Cardiac anomalies, Metabolic anomalies (Diabetes, Thyroid, etc.), Pulmonary anomalies, Urinary anomalies, Renal anomalies, Hematological anomalies (sickle cell disease, anemia, etc.)
Measured: at inclusion
Describe the events that occurred in children by type of disorders
events are :Eye disorders, Developmental disorders, Language disorders, Hearing disorders, Bone and joint disorders, Cardiac anomalies, Metabolic anomalies (Diabetes, Thyroid, etc.), Pulmonary anomalies, Urinary anomalies, Renal anomalies, Hematological anomalies (sickle cell disease, anemia, etc.)
Measured: at inclusion
Describe the reasons for non-inclusions
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Mar 2024
- Primary completion20 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus-HIVStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Bachelard, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666543
- Sponsor's protocol ID
- APHP231638
- Other IDs
- 2023-A02060-45
- Acronym
- ENIVIH
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital
- ClinicalTrials.gov ID
- NCT06666543
- Acronym / sponsor ID
- ENIVIH / APHP231638
- Conditions
- Virus-HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 30 Oct 2024 (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 strategies for the Prevention of Mother-to-Child Transmission of the Human Immunodeficiency Virus (HIV) are very effective and have become common practices in many contexts.
Some studies have identified clinical and biological anomalies in a small proportion of infants exposed to antiretrovirals. Beyond 2 years of age, there are few studies with low power describing the long-term consequences of perinatal exposure to antiretrovirals.
It is necessary to understand the impact of antiretroviral treatment during the perinatal period in order to improve the management of children born to HIV-positive mothers.
Retrospective cohort study with interviews of women living with HIV who were followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France.
After recruitment during a follow-up consultation:
- Information regarding the prenatal and perinatal management of HIV and the infant's outcomes up to 12 months will be collected retrospectively through the medical record
- Information regarding the child's development and follow-up from the age of 1 to a maximum of 15 years will be gathered retrospectively through a self-administered questionnaire or a questionnaire filled out with assistance during a single 1-hour interview with the mother."
Detailed description
The latest WHO report shows that with 1.3 million (between 970,000 and 1.6 million) HIV-positive pregnant women worldwide in 2020, HIV remains a major global public health issue.
In France, about 2 per 1,000 pregnant women are infected with HIV, resulting in approximately 1,500 births per year over the past fifteen years. The administration of antiretroviral treatment to HIV-positive pregnant women and prophylaxis for infants immediately after birth is the most effective means of preventing mother-to-child transmission (MTCT) of HIV. This risk has been estimated at 0.2% during the period from 2011 to 2017 among women included in the French perinatal survey.
While the number of children infected with HIV is decreasing due to wider access to antiretroviral treatments during pregnancy, the number of HIV-exposed but uninfected children is increasing, raising questions about their long-term outcomes.
Some historical studies have identified clinical and biological anomalies, including lactic acidosis, cardiomyopathy, and neurological anomalies, suggesting mitochondrial dysfunction in a small proportion of uninfected children exposed to antiretrovirals.
Since then, recent studies have provided new evidence suggesting that HIV-exposed but uninfected children, while avoiding vertical transmission of HIV, are at a higher risk of suboptimal health outcomes, including higher rates of severe infectious morbidity, lower early childhood survival, and more frequent occurrences of growth delay and neurological development issues compared to children born without HIV exposure.
Additionally, concerns have been raised about neural tube closure anomalies in children exposed to efavirenz and dolutegravir at the time of conception. However, recent data showed that the prevalence of neural tube closure anomalies did not differ significantly between dolutegravir and other antiretrovirals since conception.
Nonetheless, some studies have acknowledged methodological weaknesses, indicating that further research is needed to evaluate each medication individually and how antiretroviral treatment regimens affect the outcomes of infants during the perinatal period.
Consensus guidelines recommend follow-up for HIV-exposed but uninfected children up to 24 months of age. Currently, there is no active long-term follow-up program in France for asymptomatic children. Follow-up may be extended if the child presents a clinical or biological anomaly. Families should be informed of the importance of reporting significant clinical events to their healthcare provider and/or the center that monitored the child in the early months of life. The healthcare provider managing the mother may also play a role in the long-term screening of significant clinical events in the child by gathering information from the mother he or she follows.
Beyond 2 years of age, there are few studies with low power describing the long-term consequences of in utero or perinatal exposure to antiretrovirals.
The participation of children and their parents in observational studies is essential for research, necessary to monitor and identify long-term health outcomes following perinatal exposure to HIV and antiretrovirals.
The objective of this retrospective study is to describe the outcomes of HIV-exposed but uninfected children born to HIV-positive mothers followed at Bichat-Claude Bernard Hospital
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women Living with HIV | – | Other: QuestionaryWomen Living with HIV Who Have Given Birth to HIV-Exposed, Uninfected Children |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- woman followed in the SMIT of Bichat-Claude Bernard Hospital, who gave birth at the maternity ward of this hospital between 01/01/2007 and 31/12/2022 to a child who is HIV-uninfected
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Not speaking French"
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 |
|---|---|---|
| QuestionaryThe questionnaire will address the following topics for each child who is not infected with HIV and was born to an infected mother at the time of birth: * Pregnancy progression * Immediate postpartum course * Medical development of the child from 0 to 3 years * Medical development of the child from 3 to a maximum of 15 years | Other | Women Living with HIV |
Primary outcome
Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years)
Time frame: 1 day
Clinical events of interest will be collected through a survey from the mother (Eye disorders, Developmental disorders, Language disorders, Hearing disorders, Bone and joint disorders, Cardiac anomalies, Metabolic anomalies (Diabetes, Thyroid, etc.), Pulmonary anomalies, Urinary anomalies, Renal anomalies, Hematological anomalies (sickle cell disease, anemia, etc.))
7 secondary outcomes
Describe the course of the pregnancy
Time frame: at inclusion
Describe the course of the immediate postpartum period
Time frame: at inclusion
Describe the medical follow-up of children between 0 and 3 years old
Time frame: at inclusion
Describe the medical follow-up of children between 3 and 15 years old
Time frame: at inclusion
Describe the events that occurred in children by age group
Time frame: at inclusion
Describe the events that occurred in children by type of disorders
Time frame: at inclusion
Describe the reasons for non-inclusions
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
Antoine Bachelard principal investigator
Assistance Publique - Hôpitaux de Paris
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 Virus-HIV, run by Assistance Publique - Hôpitaux de Paris 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 0 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years) (time frame: 1 day). 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 1 Aug 2025.