The Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children in Cameroon: The PREVENT-IT Study
Sponsor study identifier
observational
400
1 country
3
Study Start
October 1, 2017
Actual (reported)Primary Completion
April 30, 2019
Actual (reported)Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2017
Actual (reported)April 30, 2019
Actual (reported)August 26, 2019
Actual (reported)August 28, 2019
Actual (reported)December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Difference in urinary RBP, NAG, KIM-1and B2M levels at birth between neonates born to mothers living with HIV, exposed in utero to TDF and those born to mothers without HIV and not exposed to TDF
In urine samples collected at birth from HIV-EU TDF-exposed neonates and an equal number of TDF-unexposed controls, RBP, KIM-1, B2M will be measured using multianalyte platform (xMAP) assay, while NAG will be measured using ELISA. Levels of these correlates of proximal tubular function will be compared between the two groups, adjusting for confounders
Birth
Difference in urinary RBP, NAG, KIM-1and B2M levels after birth and within the first year of life between HEU infants, exposed in utero to TDF and HUU infants, not exposed to TDF
Trends in urinary RBP:Cr, NAG:Cr, KIM-1 and B2M will be tracked during and beyond breastfeeding between HIV-EU TDF+ and unexposed controls by conducting serial measurements of these markers at 6 weeks then 3, 6, 12 months using same methods described in outcome 1
0 to 12 months
These are children to women who are living with HIV but who are not infected with the virus (HIV PCR results at 6 weeks is negative)
These are children born to women who are not infected with HIV
Exposed in utero and during breastfeeding to Tenofovir-containing antiretroviral drugs
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Our study population will be primarily made up of mother-infant pairs with and without infant exposure in utero to TDF and HIV
CASS
Yaoundé, Cameroon
Cité Verte DH
Yaoundé, Cameroon
Efoulan DH
Yaoundé, Cameroon
Mothers: Peripheral blood (delivery) Infants: Coord blood, urine, peripheral blood
Gabriel L Ekali, MD,MH
University of Yaounde 1
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
October 1, 2017
Actual (reported)Primary Completion
April 30, 2019
Actual (reported)Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury
Contact the study team to confirm eligibility.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 29, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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