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Prevention of Mother-to-child Transmission of HIV-1 Using a Responsive Intervention

NCT03870438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1506

Last updated 2022-12-07

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

In the intervention arm, HIV-1 negative children with HIV-1 positive mothers who have an HIV-1 viral load ≥ 1000 copies/ml will receive lamivudine syrup orally (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). The intervention will last a maximum of 10 months (until the baby is 12 months old or until the confirmed end of breastfeeding). Breastfeeding will be considered to be ceased if the mother confirms she is no longer breastfeeding for 2 consecutive monthly visits

Sponsors & Collaborators

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • Centre Muraz

    collaborator OTHER

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

    collaborator OTHER_GOV

  • University of Bergen

    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
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-14
Primary Completion
2022-09-12
Completion
2022-10-31

Countries

  • Burkina Faso
  • Zambia

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 NCT03870438 on ClinicalTrials.gov