NCT03235310

Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention

ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 18,200 (estimated)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

Detailed description

The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout France, except in case of refusal. Maternal clinical, biological and therapeutic data before and during pregnancy are collected at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and 24 months. An infant is considered as non infected if two virologic tests are negative beyond the prophylactic treatment or serology is negative after 18 months. An infant is considered as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific recommendation for HIV treatment and obstetrical care are made for women and children included in the cohort, although national guidelines for prevention of MTCT are regularly published and updated. Frozen maternal samples blood and plasma are stored in a centralized laboratory. A research of patients patients lost to follow-up (last visit \<24 months) and monitoring is performed regularly in all sites.

Conditions

• Mother to Child Transmission of HIV

Timeline

• Start date: 1997-07-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2017-08-01
• Last updated: 2021-04-13

Locations

28 sites across 1 country: France