Understanding the health of children born to HIV-positive mothers
Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed At Bichat Claude Bernard Hospital
This study looks at the long-term health of children born to mothers with HIV who received treatment during pregnancy to see how it affects their health in the first year of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06666543 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term health outcomes of children who were exposed to antiretroviral treatments during pregnancy but are HIV-uninfected. It involves a retrospective cohort analysis where women living with HIV, who gave birth at Bichat-Claude Bernard Hospital, will be interviewed to gather information about their prenatal and perinatal management and the health of their children up to 12 months of age. The study seeks to identify any clinical and biological anomalies in these children to improve future management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older living with HIV who gave birth to at least one HIV-uninfected child at Bichat-Claude Bernard Hospital between 2007 and 2022.
Not a fit: Patients who do not speak French or refuse to participate in the study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved health management and outcomes for children born to HIV-positive mothers.
How similar studies have performed: While some historical studies have indicated potential health issues in HIV-exposed but uninfected children, this study aims to provide new insights and is considered novel in its approach.
Eligibility criteria
Show full inclusion / exclusion criteria
"Inclusion Criteria * Woman living with HIV followed for HIV infection at Bichat-Claude Bernard Hospital * Age ≥ 18 years * Having given birth at the maternity ward of Bichat-Claude Bernard Hospital between 01/01/2007 and 31/12/2022 to at least one child who is HIV-uninfected * Information provided about the study and the right to refuse participation Exclusion Criteria * Refusal to participate in the study * Not speaking French"
Where this trial is running
Paris
- Hôpital Bichat-Claude Bernard — Paris, France (Recruiting)
Study contacts
- Principal investigator: Antoine Bachelard — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Antoine Bachelard
- Email: antoine.bachelard2@aphp.fr
- Phone: 01 40 25 62 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.