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

NCT06666543 | Completed

• 2 other identifiers: APHP2316382023-A02060-45
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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."

Conditions

Virus-HIV

Outcome Measures

Primary Outcomes (1)

• 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.))

  1 day

Secondary Outcomes (7)

• Describe the course of the pregnancy

  at inclusion

• Describe the course of the immediate postpartum period

  at inclusion

• Describe the medical follow-up of children between 0 and 3 years old

  at inclusion

• Describe the medical follow-up of children between 3 and 15 years old

  at inclusion

• Describe the events that occurred in children by age group

  at inclusion

Study Arms (1)

Women Living with HIV

Women Living with HIV Who Have Given Birth to HIV-Exposed, Uninfected Children

Other: Questionary

Interventions

Questionary OTHER

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

Women Living with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Antoine Bachelard

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 30, 2024
• Study Start: March 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

FR (1)