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NCT06666543Completed

Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital

Source: ClinicalTrials.gov · Last updated 1 Aug 2025

Brief summary (registry, in English)

"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."

Status (registry)
Completed
Study type
Observational
Enrollment
172 (actual)
First submitted
18 Oct 2024
Start date
20 Mar 2024
Primary completion date
20 Mar 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06666543

What you commit to

  • Study type: Observational
  • Participants enrolled: 172
  • From 20 Mar 2024 to the primary completion date, 20 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Refusal to participate in the study
  • Not speaking French"

Criteria the registry did not label

  • "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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hôpital Bichat - Claude-Bernard
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.