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

NCT ID: NCT04070482

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-12-31

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 both in macaques and HIV-infected adults and infants. Therefore concerns have been raised about its renal safety in exposed infants of women on Option B+. Data for HEU is sparse and routine measures of renal function (creatinine, proteinuria), may not be appropriate to detect TDF-associated renal injury early. The goal of our study is to assess whether TDF use in pregnancy and breastfeeding affects the function of the kidney function of the child. Pregnant women who consent during their first antenatal consultation to take antiretroviral drugs for PMTCT after testing positive, will be enrolled and followed till birth, for adherence using HPLC. Their terms infants who are HIV negative by DNA PCR at 6 weeks (HEU), will have urine collected at 1.5, 3, 6, 9 months. Using appropriate and more sensitive markers (RBP4, KIM1, NAG, β2M), proximal tubular function will be assessed in 159 HEU infants and same number of controls. Nutritional status and drug history data will be collected for both mother and child. RBP, KIM1, β2M will be measured using XMAP assay while ELISA will be used for NAG according to manufacturer recommendations. Creatinine, phosphates and urinary tract infection will be measured using standard methods. Values of these markers will be compared between the 2 groups. Results will confirm/infirm renal safety of TDF in pregnancy, improve prevention of long term renal injury through early detection, contribute to promote development of routine rapid diagnostic tests for acute renal tubular injury

Conditions

Renal Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Tenofovir exposure in utero and during breastfeeding

Intervention Type: OTHER

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

HIV-unexposed uninfected infants

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

No interventions assigned to this group

Interventions

Tenofovir exposure in utero and during breastfeeding

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mothers

1. HIV seropositive pregnant women on Option B+ protocol containing TDF.

2. HIV seronegative pregnant women

3. Pregnant women who provide informed consent.

4. Woman is living in Yaounde and is not planning to relocate in the next 2 years. Children

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1. Children born to HIV-infected mothers (and HIV-uninfected mothers for controls).

2. TDF- and HIV-exposed in utero (and age-matched unexposed controls).

3. 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 Criteria

• Refusal of parent(s) to give consent

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University of Yaounde 1

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Loni Ekali

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriel L Ekali, MD,MH

Role: PRINCIPAL_INVESTIGATOR

University of Yaounde 1

Locations

CASS

Yaoundé, , Cameroon

Cité Verte DH

Yaoundé, , Cameroon

Efoulan DH

Yaoundé, , Cameroon

Countries

Cameroon

Other Identifiers

2016/449-LON

Identifier Type: -

Identifier Source: org_study_id