Status:
UNKNOWN
Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Centre Muraz
Conditions:
HIV-1
Eligibility:
FEMALE
15+ years
Phase:
PHASE2
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 t...
Detailed Description
The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant or breastfeeding women represents a major advance for universal access to HIV care but this strategy alone...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03869944
Start Date
December 4 2019
End Date
March 1 2022
Last Update
March 31 2022
Active Locations (1)
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1
Paulin Fao
Bobo-Dioulasso, Burkina Faso