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Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV

NCT03869944 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-03-31

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Lamivudine Oral Solution

During the EPI-2 visit, HIV-1 negative children of mothers with a unsuppressed plasma HIV-1 VL (≥ 1000 copies/mL) will be initiated on PrEP, lamivudine syrup (7.5 mg twice daily if 2 to 4 kg; 25 mg twice a day if weight \<8 kg; and 50 mg twice a day if weight \>8 kg) for 10 months, until the child is 12 months old. A monitoring on the mother's VL and child's diagnosis will take place at 6 and 12 months. Mothers with unsuppressed plasma HIV-1 VL (\< 1000 copies/mL) and HIV-1 negative children will not be offered PrEP but the mother's VL and child diagnosis will be monitored at 6 and 12 months: If the VL is ≥ 1000 copies/mL, the child will be initiated on PrEP until the child is 12 months old. Children infected with HIV-1 will be referred to the National Program for immediate ART.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Centre Muraz

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Philippe Van de Perre, MD, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869944 on ClinicalTrials.gov