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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,506

Participants

Timeline

Start Date

December 14, 2019

Primary Completion Date

September 12, 2022

Study Completion Date

October 31, 2022

Conditions
HIV-1
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

Trial Locations (6)

Unknown

CSPS and CMA of Do and Dafra districts, Bobo-Dioulasso

CSPS and CMA of Baskuy and Boulmiougou districts, Ouagadougou

Bauleni, Lusaka

Chaisa, Lusaka

Chilenje Level 1 hospital, Lusaka

Matero Main, Lusaka

All Listed Sponsors
collaborator

University Teaching Hospital, Lusaka, Zambia

OTHER

collaborator

Centre Muraz

OTHER

collaborator

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

OTHER_GOV

collaborator

University of Bergen

OTHER

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT03870438 - Prevention of Mother-to-child Transmission of HIV-1 Using a Responsive Intervention | Biotech Hunter | Biotech Hunter