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HIV NephropathyGEN-AFRICANCT05685810

Genetic Determinants of Kidney Disease in People of African Ancestry With HIV

An observational study of HIV Nephropathy and Kidney Injury, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Black ethnicity is a major risk factor for chronic kidney disease [CKD] in people with HIV infection, suggesting that genetic factors are an important determinant of kidney disease progression in this population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Nephropathy, Kidney Injury, Kidney Diseases
How many people
3,029 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2018to 31 Jan 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Black people with HIV infection who received care at one of 15 HIV clinics in the United Kingdom.

Who may be able to join

  • HIV positive
  • Black ethnicity (self-identified)
  • Informed consent

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RJ

Other trials in United Kingdom

About this study

Official title: Genetic and Clinical Determinants of Cardiovascular Disease, Diabetes, Kidney Disease and Obesity in People of African Ancestry With HIV

Black ethnicity is a major risk factor for chronic kidney disease [CKD] in people with HIV infection, suggesting that genetic factors are an important determinant of kidney disease progression in this population. The Gen-Africa study was established in 2018 to allow the study of genetic and clinical risk factors for CKD in people with HIV in the UK. Just over 3000 people across 15 sites were enrolled between May 2018 and January 2020. Demographic and clinical information was collected, and biological samples (buffy coats, plasma and urine) obtained. Cross-sectional analyses have revealed that participants of West-African ancestry are at higher risk of CKD and end-stage kidney disease [ESKD], and that genetic variants in the apolipoprotein L1 (APOL1) gene and sickle cell trait (SCT) are predictors of CKD and ESKD. The pathogenesis of APOL1- and SCT-associated CKD is incompletely understood, and additional, longitudinal data will be collected to improve understanding of the contribution of demographic, traditional CKD (diabetes, hypertension, obesity/metabolic syndrome, cardiovascular disease) and HIV (immuno-virological and hepatitis B/C co-infection status, antiretroviral medications) risk factors as well as additional genetic and epigenetic markers.

Read the detailed description

At enrolment, just over 3,000 people of (self-identified) back ethnicity provided informed consent, a blood and urine sample, weight, height, and blood pressure measurements, and completed a short questionnaire about your health issues and lifestyle factors. HIV treatment history, including most recent and nadir CD4 count and HIV viral load, viral hepatitis status and kidney function measurements were recorded. Records for about 2,350 participants have been successfully linked to the United Kingdom Collaborative HIV Cohort (UK CHIC) which has collected data (demographics, clinical and laboratory parameters) on people with HIV since 1998 at selected clinics in the United Kingdom.

Several GEN-AFRICA sub-studies (CKD-AFRICA, Coronavirus disease (CoV)-AFRICA, Ob-AFRICA) have been conducted or are being planned. Each of these studies has received, or will be submitted for, regulatory approval. The studies have allowed or will allow collection of more detailed clinical information, additional biological samples, and/or through linkage with electronic clinical records, collection of longitudinal data on HIV (CD4, HIV viral load, AIDS-defining illnesses, and details of antiretroviral therapy), comorbidities (diabetes, hypertension, kidney disease, cardiovascular events), measurements such as blood pressure and weight, and results of blood tests including measures of kidney function performed as part of clinical monitoring.

Data collected as part of the GEN-AFRICA study / sub-studies are stored at King's College Hospital under their GEN-AFRICA/CKD-AFRICA/CoV-AFRICA/Ob-AFRICA study identifiers (ID). Samples collected as part of these protocols are labeled by study ID and stored in the James Black Building, King's College London, London, UK, in compliance with human tissue act (HTA) standards. Prof. Frank post is the custodian of the data and samples and will be responsible for ensuring all study activity is compliant with relevant data protection and other policies.

Medical subject headings
AIDS-Associated Nephropathy, Kidney Diseases, Diabetes Mellitus, Obesity, Cardiovascular Diseases, Genetic Predisposition to Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kidney disease

    Incidence and predictors of end-stage kidney disease, chronic kidney disease, HIVAN, focal and segmental glomerulosclerosis (FSGS), tenofovir disoproxil fumarate (TDF)-associated kidney injury.

    Measured: 2018-2030

Secondary outcomes (6)

  1. Coronavirus disease (COVID-19)

    Incidence and clinical and genetic determinants of COVID-19

    Measured: 2020-2023

  2. Multi-morbidity

    Clinical and social determinants of multi-morbidity

    Measured: 2019-2023

  3. Weight change

    Weight change in relation to antiretroviral exposures

    Measured: 2013-2024

  4. Obesity

    Incidence of obesity in relation to antiretroviral exposures

    Measured: 2013-2024

  5. Dysglycaemia

    Relationship between fasting blood glucose/HbA1c and waist circumference/BMI

    Measured: 2019-2023

  6. Insulin resistance

    Relationship between fasting blood glucose/HbA1c, insulin/C-peptide, and waist circumference/BMI

    Measured: 2019-2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start1 May 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2030 (estimated)

Resources

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
Other
Enrolment
3,029 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685810
Sponsor's protocol ID
239895
Acronym
GEN-AFRICA
Status last verified
Feb 2025
First submitted
3 Jan 2023
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The database contains personal and sensitive information and is therefore not publicly available. Access to the study data and/or samples is governed by the National Health Service data access policy and those of King's College Hospital National Health System (NHS) Foundation Trust, the study sponsor. The Gen-AFRICA cohort is open to collaborations, and all requests from researchers who meet the criteria for access to fully anonymized patient level data will be considered.

Publications

  • Ottaway Z, Campbell L, Fox J, Burns FM, Hamzah L, Schoeman S, Price D, Clarke A, Pett SL, Onyango D, Sabin C, Miller RF, Post FA; COVID-AFRICA study group. Post-acute sequelae of COVID-19 in people of Black ethnicities living with HIV in the United Kingdom. Int J STD AIDS. 2025 Jul;36(8):602-610. doi: 10.1177/09564624251334227. Epub 2025 Apr 14.

    PubMed 40227084

  • Moon Z, Campbell L, Ottaway Z, Fox J, Burns F, Hamzah L, Ustianowski A, Clarke A, Schoeman S, Sally D, Tariq S, Post FA, Horne R. Mapping Vaccination Mindsets among UK Residents of Black Ethnicities with HIV: Lessons from COVID-19. AIDS Behav. 2025 May;29(5):1516-1524. doi: 10.1007/s10461-025-04622-0. Epub 2025 Mar 10.

    PubMed 40063203

  • Ottaway Z, Onyango D, Kolodin V, Carter A, Horne R, Campbell L, Hamzah L, Post FA, Tariq S, Nicholls EJ. 'COVID impacted my life in so many ways': a qualitative study of the lived experiences of the COVID-19 pandemic among people of Black ethnicities living with HIV in England. Ethn Health. 2025 Feb;30(2):254-272. doi: 10.1080/13557858.2024.2429405. Epub 2024 Nov 26.

    PubMed 39593273

  • Kolodin V, Barbini B, Onyango D, Musomba R, Liu J, Hung RKY, Nikiphorou E, Campbell L, Post FA, Tariq S, Lempp H. Social determinants of health and long-term conditions in people of Black African and Black Caribbean ethnicity living with HIV in London: A qualitative study. Health Expect. 2024 Jun;27(3):e14055. doi: 10.1111/hex.14055.

    PubMed 38666627

  • Patel N, Post FA. Surveillance for hepatocellular carcinoma in people of African ancestry with HIV and Hepatitis B. Int J STD AIDS. 2022 Feb;33(2):202-204. doi: 10.1177/09564624211042828. Epub 2021 Sep 21.

    PubMed 34546112

  • Ko S, Dominguez-Dominguez L, Ottaway Z, Campbell L, Fox J, Burns F, Hamzah L, Ustianowski A, Clarke A, Kegg S, Schoeman S, Jones R, Pett SL, Hudson J, Post FA. Cardiovascular disease risk in people of African ancestry with HIV in the United Kingdom. HIV Med. 2024 Dec;25(12):1289-1297. doi: 10.1111/hiv.13706. Epub 2024 Aug 29.

    PubMed 39209512

  • Ottaway Z, Campbell L, Fox J, Burns F, Hamzah L, Kegg S, Rosenvinge M, Schoeman S, Price D, Jones R, Miller RF, Tariq S, Post FA. HIV outcomes during the COVID-19 pandemic in people of Black ethnicities living with HIV in England. HIV Med. 2024 Jul;25(7):885-892. doi: 10.1111/hiv.13640. Epub 2024 Mar 26.

    PubMed 38529684

  • Ottaway Z, Campbell L, Cechin LR, Patel N, Fox J, Burns F, Hamzah L, Kegg S, Rosenvinge M, Schoeman S, Price D, Jones R, Clarke A, Maan I, Ustianowski A, Onyango D, Tariq S, Miller RF, Post FA; COVID-AFRICA study group. Clinical epidemiology of COVID-19 in people of black ethnicity living with HIV in the UK. HIV Med. 2024 May;25(5):614-621. doi: 10.1111/hiv.13611. Epub 2024 Jan 11.

    PubMed 38213094

  • Dominguez-Dominguez L, Hamzah L, Fox J, Vincent RP, Post FA. Brief Report: Cystatin C Provides Substantially Higher Glomerular Filtration Rate Estimates Than Creatinine in a Subset of Black People With HIV on Current Antiretroviral Regimens. J Acquir Immune Defic Syndr. 2025 Feb 1;98(2):171-175. doi: 10.1097/QAI.0000000000003555.

    PubMed 39791983

  • Cechin L, Dominguez-Dominguez L, Campbell L, Hamzah L, Fox J, Vincent RP, Dimitriadis GK, Goff L, Post FA. Waist circumference and cardiometabolic parameters in people of African/Caribbean ancestry with HIV in South London (CKD-AFRICA study). Int J STD AIDS. 2024 Jun;35(7):521-526. doi: 10.1177/09564624241233036. Epub 2024 Feb 20.

    PubMed 38377277

  • Dominguez-Dominguez L, Campbell L, Barbini B, Fox J, Nikiphorou E, Goff L, Lempp H, Tariq S, Hamzah L, Post FA. Associations between social determinants of health and comorbidity and multimorbidity in people of black ethnicities with HIV. AIDS. 2024 May 1;38(6):835-846. doi: 10.1097/QAD.0000000000003848. Epub 2024 Feb 1.

    PubMed 38265411

  • Hung RKY, Costeira R, Chen J, Schlosser P, Grundner-Culemann F, Booth JW, Sharpe CC, Bramham K, Sun YV, Marconi VC, Teumer A, Winkler CA, Post FA, Bell JT. Epigenetic associations with kidney disease in individuals of African ancestry with APOL1 high-risk genotypes and HIV. Nephrol Dial Transplant. 2025 Apr 28;40(5):997-1006. doi: 10.1093/ndt/gfae237.

    PubMed 39448372

  • Hung RKY, Santana-Suarez B, Binns-Roemer E, Campbell L, Bramham K, Hamzah L, Fox J, Burns JE, Clarke A, Vincent R, Jones R, Price DA, Onyango D, Harber M, Hilton R, Booth JW, Sabin CA, Winkler CA, Post FA; GEN-AFRICA study group. The epidemiology of kidney disease in people of African ancestry with HIV in the UK. EClinicalMedicine. 2021 Jul 8;38:101006. doi: 10.1016/j.eclinm.2021.101006. eCollection 2021 Aug.

    PubMed 34286237

  • Hung RKY, Binns-Roemer E, Booth JW, Hilton R, Harber M, Santana-Suarez B, Campbell L, Fox J, Ustianowski A, Cosgrove C, Burns JE, Clarke A, Price DA, Chadwick D, Onyango D, Hamzah L, Bramham K, Sabin CA, Winkler CA, Post FA; GEN-AFRICA Study Group. Genetic Variants of APOL1 Are Major Determinants of Kidney Failure in People of African Ancestry With HIV. Kidney Int Rep. 2022 Jan 25;7(4):786-796. doi: 10.1016/j.ekir.2022.01.1054. eCollection 2022 Apr.

    PubMed 35497797

  • Hung RKY, Binns-Roemer E, Booth JW, Hilton R, Fox J, Burns F, Harber M, Ustianowski A, Hamzah L, Burns JE, Clarke A, Price DA, Kegg S, Onyango D, Santana-Suarez B, Campbell L, Bramham K, Sharpe CC, Sabin CA, Winkler CA, Post FA; GEN-AFRICA Study Group. Sickle Cell Trait and Kidney Disease in People of African Ancestry With HIV. Kidney Int Rep. 2021 Dec 13;7(3):465-473. doi: 10.1016/j.ekir.2021.12.007. eCollection 2022 Mar.

    PubMed 35257059

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Nephropathy and Kidney Injury, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

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 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Kidney disease (time frame: 2018-2030). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685810, which also lists 19 linked publications.

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 3 Sep 2025.

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