Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children

NCT04070482 | Unknown DMC

• 1 other identifier: 2016/449-LON
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

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

Conditions

Renal Injury

Keywords

Tenofovir; HIV-exposed infants; renal injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

HIV-exposed uninfected infants

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)

Other: Tenofovir exposure in utero and during breastfeeding

HIV-unexposed uninfected infants

These are children born to women who are not infected with HIV

Interventions

Tenofovir exposure in utero and during breastfeeding OTHER

Exposed in utero and during breastfeeding to Tenofovir-containing antiretroviral drugs

HIV-exposed uninfected infants

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Our study population will be primarily made up of mother-infant pairs with and without infant exposure in utero to TDF and HIV

You may qualify if:

• 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)

You may not qualify if:

• Refusal of parent(s) to give consent

Sponsors & Collaborators

• University of Yaounde 1: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

CASS

Yaoundé, Cameroon

Location

Cité Verte DH

Yaoundé, Cameroon

Location

Efoulan DH

Yaoundé, Cameroon

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mothers: Peripheral blood (delivery) Infants: Coord blood, urine, peripheral blood

Study Officials

• Gabriel L Ekali, MD,MH

  University of Yaounde 1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: December 1, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

CA (3)