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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: Centre Muraz; Institut National de la Santé Et de la Recherche Médicale, France; University of Bergen; University Teaching Hospital, Lusaka, Zambia
• Treatments: Lamivudine

Criteria

For HIV+ women who give consent, the measurement of their HIV-1 viral load and the detection of HIV-1 DNA in their children will be assessed.

Inclusion Criteria:

A mother/infant pair will be included in the Phase III trial if the infant:

• Is a singleton

• Is breastfed at 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)

• Has a negative HIV-1 PCR POC test at 2 months of age

• Has a mother who:

• Is the accompanying person to visit 2 of the EPI

• Is 15 years of age or older (in Zambia) and 20 years of age or older (in Burkina Faso) or

• If between 15 and 19 years of age (inclusive) in Burkina Faso, and is accompanied by a referent adult of her choice representing her interests and the interests of the child (parent, family member or guardian, member of an association, etc.)

• Has been confirmed to be infected with HIV-1 (with or without HIV-2)

• Has signed the consent form to participate For the mother in Zambia, the consent must be signed by herself and a witness; For the mother in Burkina Faso, the consent must be signed by herself and a witness (if illiterate) and/or a referent adult (if under 20 years of age in Burkina Faso).

For the child in Zambia, the consent must be signed by the mother. For the child in Burkina Faso, the consent must be signed by the mother and/or a referent adult (if under 20 years of age in Burkina Faso. In Burkina Faso, both parents need to sign the consent unless the mother exercises sole parental authority or if obtaining the father's consent is likely to endanger the mother and her child. In Zambia, the mother exercises sole parental authority.

Exclusion Criteria:

A mother-child couple will not be included if the child:

• Has clinical symptoms or biological abnormalities of DAIDS classification 3 or 4 for adverse events on the day of inclusion

• Has a severe congenital malformation

• Has a known allergy to the study drug or its components

• Takes emtricitabine concomitantly

• Has a mother who:

• Lives outside the study area or intending to move from the area within the next 12 months

• Is participating in another clinical trial