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

NCT03869944 | Unknown Phase 2 DMC

• 1 other identifier: ANRS 12388 PREVENIR-PEV
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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

HIV-1

Keywords

HIV-1; PMTCT; Point of Care; PrEP; Burkina Faso; Expanded Program of Immunization (EPI)

Outcome Measures

Primary Outcomes (1)

• Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children

  Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding.

  12 months

Secondary Outcomes (4)

• Efficacy of PMTCT cascade - mother

  2 months

• Efficacy of PMTCT cascade - child

  2 months

• Access to ART for HIV-1-positive children

  6 months

• Number of Adverse Events Grade 3 and 4 in the prevention of HIV-1 via breastfeeding [Safety of lamivudine]

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Lamivudine Oral Solution

Drug: Lamivudine Oral Solution

Interventions

Lamivudine Oral Solution DRUG

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.

Intervention

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: HIV-1-positive breastfeeding mothers of HIV-1-negative children (female or male)
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A mother-child couple will be included in the Phase IIb trial if the child:
• is a singleton
• is breastfed at about 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)
• has a POC HIV-1 PCR negative test at about 2 months of age
• has a mother who:
• accompanies him to visit 2 of the EPI
• is over 20 years of age or over or is a minor from the age of 15 and is accompanied by a referent adult of his/her choice representing his/her interests (parent, family member or guardian, member of an association, etc.)
• has been confirmed to be infected with HIV-1 (with or without HIV-2)
• signature of the consent to participate
• for the mother signed by herself and a witness (if illiterate) and/or a referent adult (if under 20 years of age)
• for the child: consent must be signed by both parents unless the mother exercises parental authority alone or if obtaining the father's consent is likely to endanger the mother and her child.

You may not qualify if:

• A mother-child couple will not be included in the Phase IIb trial if the child:
• has a severe congenital malformation
• has a known allergy to the study drug or its components
• is taking emtricitabine concomitantly
• has a mother:
• living outside the study area or planning to move from the area within the next 12 months

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Muraz: collaborator

Study Sites (1)

Paulin Fao

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (3)

• Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, Mwiya M, Kwagala M, Traore H, Sunday A, Singata M, Siuluta C, Some E, Rutagwera D, Neboua D, Ndeezi G, Jackson D, Marechal V, Neveu D, Engebretsen IMS, Lombard C, Blanche S, Sommerfelt H, Rekacewicz C, Tylleskar T, Van de Perre P; ANRS 12174 Trial Group. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016 Feb 6;387(10018):566-573. doi: 10.1016/S0140-6736(15)00984-8. Epub 2015 Nov 19.

  PMID: 26603917 BACKGROUND

• Mennecier A, Sakana BLD, D'Ottavi M, Tassembedo S, Moles JP, Kania D, Taofiki AO, Kadeba FE, Diallo I, Eymard-Duvernay S, Meda N, Mosqueira B, Fao P, Nagot N; PREVENIR-PEV Study Group; Vande Perre P. An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV). BMC Infect Dis. 2024 Sep 20;24(1):1014. doi: 10.1186/s12879-024-09910-z.

  PMID: 39300364 DERIVED

• Mennecier A, Kankasa C, Fao P, Moles JP, Eymard-Duvernay S, Mwiya M, Kania D, Chunda-Liyoka C, Sakana L, Rutagwera D, Tassembedo S, Wilfred-Tonga MM, Mosqueira B, Tylleskar T, Nagot N, Van de Perre P; ANRS 12397 Study group. Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso. Contemp Clin Trials. 2021 Jun;105:106402. doi: 10.1016/j.cct.2021.106402. Epub 2021 Apr 17.

  PMID: 33872801 DERIVED

MeSH Terms

Interventions

Lamivudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Philippe Van de Perre, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Phase II trial, non-randomized, open-label, mono-country and multi-center trial

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 11, 2019
• Study Start: December 4, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BU (1)