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

• Status: Recruiting
• Trial end date: 2022-03-01
• 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 2
• 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
• 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-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.

Exclusion Criteria:

A mother-child couple will not be included in the Phase IIb trial if the child:

• exhibits DAIDS grade 3 or 4 clinical symptoms or biological anomalies for adverse events on the day of inclusion

• 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

• participating in another clinical trial on the day of inclusion