Status:
UNKNOWN
Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children
Lead Sponsor:
University of Yaounde 1
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Renal Injury
Eligibility:
All Genders
Up to 1 years
Brief Summary
The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants
Detailed Description
There is a growing use of Tenofovir (TDF) in sub-Saharan Africa with the use of Option B+ for prevention of mother-to-child HIV transmission. TDF has been associated to renal function abnormalities bo...
Eligibility Criteria
Inclusion
- Mothers
- HIV seropositive pregnant women on Option B+ protocol containing TDF.
- HIV seronegative pregnant women
- Pregnant women who provide informed consent.
- Woman is living in Yaounde and is not planning to relocate in the next 2 years. Children
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- Children born to HIV-infected mothers (and HIV-uninfected mothers for controls).
- TDF- and HIV-exposed in utero (and age-matched unexposed controls).
- HIV negative after birth by DNA PCR 4.0 to 12 months of age (included in study at birth and followed up till 12 months)
Exclusion
- Refusal of parent(s) to give consent
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04070482
Start Date
October 1 2017
End Date
December 1 2019
Last Update
August 29 2019
Active Locations (3)
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1
CASS
Yaoundé, Cameroon
2
Cité Verte DH
Yaoundé, Cameroon
3
Efoulan DH
Yaoundé, Cameroon