Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.

NCT03869944 Phase 2 UNKNOWN

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

Details

Lead sponsor	ANRS, Emerging Infectious Diseases
Phase	Phase 2
Status	UNKNOWN
Enrolment	97
Start date	2019-12-04
Completion	2022-03

Conditions

• HIV-1

Interventions

• Lamivudine Oral Solution

Primary outcomes

• Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children — 12 months
  Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding.

Countries

Burkina Faso