Renal InjuryNCT04070482
Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children
An observational study of Renal Injury, run by University of Yaounde 1 at 3 sites in Cameroon.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Renal Injury
- What is being tested?
- Tenofovir exposure in utero and during breastfeeding
- How many people
- 400 participants
- Where
- 3 sitesCameroon
- Study dates
- 1 Oct 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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)
Who cannot join
- Refusal of parent(s) to give consent
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: The Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children in Cameroon: The PREVENT-IT Study
The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants
Read the 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
- Being tested
- Tenofovir exposure in utero and during breastfeeding
- Keywords
- Tenofovir, HIV-exposed infants, renal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir exposure in utero and during breastfeedingOther
Exposed in utero and during breastfeeding to Tenofovir-containing antiretroviral drugs
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Tenofovir exposure in utero and during breastfeeding | |
| HIV-unexposed uninfected infants | These are children born to women who are not infected with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2017
- Primary completion30 Apr 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Loni Ekali, University of Yaounde 1
- Investigators
- Gabriel L Ekali, MD,MH, Principal investigator, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070482
- Sponsor's protocol ID
- 2016/449-LON
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children in Cameroon: The PREVENT-IT Study
- ClinicalTrials.gov ID
- NCT04070482
- Acronym / sponsor ID
- 2016/449-LON
- Conditions
- Renal Injury
- Keywords
- Tenofovir, HIV-exposed infants, renal injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Yaounde 1University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-exposed uninfected infants | – | Other: Tenofovir exposure in utero and during breastfeedingThese 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) |
| HIV-unexposed uninfected infants | – | –These are children born to women who are not infected with HIV |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (9 listed)
- Mothers
- <!-- -->
Key exclusion criteria (1 listed)
- Refusal of parent(s) to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir exposure in utero and during breastfeedingExposed in utero and during breastfeeding to Tenofovir-containing antiretroviral drugs | Other | HIV-exposed uninfected infants |
Primary outcome
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
Time frame: Birth
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
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
Time frame: 0 to 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel L Ekali, MD,MH principal investigator
University of Yaounde 1
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Injury, run by University of Yaounde 1 at 3 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.