Status:
COMPLETED
Prevention of Mother-to-child Transmission of HIV-1 Using a Responsive Intervention
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
University Teaching Hospital, Lusaka, Zambia
Centre Muraz
Conditions:
HIV-1
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
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
In the vast majority of sub-Saharan African countries, all mothers attend an immunization (EPI) visit when their child is 6 to 8 weeks old (the first EPI visit for BCG and OPV0 vaccination, takes plac...
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/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
- 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
Key Trial Info
Start Date :
December 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
1506 Patients enrolled
Trial Details
Trial ID
NCT03870438
Start Date
December 14 2019
End Date
October 31 2022
Last Update
December 7 2022
Active Locations (6)
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1
CSPS and CMA of Do and Dafra districts
Bobo-Dioulasso, Burkina Faso
2
CSPS and CMA of Baskuy and Boulmiougou districts
Ouagadougou, Burkina Faso
3
Bauleni
Lusaka, Zambia
4
Chaisa
Lusaka, Zambia