Phase:Open Label
Principal Investigator(s):Philippe Van de Perre, MD, PhD
Objective:The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to: 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit. Last updated October 4, 2021
Prevention Option(s):Combination Prevention
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Intervention Children infected with HIV-1 will be referred to the National Programme for confirmed HIV diagnosis and immediate ART. For children that are not HIV-1 infected, the results on the mother's viral load will guide the next steps: Mothers with a detectable plasma viral load (≥ 1000 copies/mL): their children will be initiated on lamivudine oral solution. Mothers with an undetectable viral loads (
Mode of Delivery
Official Code: NCT03870438
Trial Sponsors: ANRS, Emerging Infectious Diseases
Start Date
End Date
December 14, 2019
June 1, 2021
Age range: 15 Years ↔ any
Population:Cisgender Women