NCT05685810: GEN-AFRICA

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

Active, enrolled Last updated 3 September 2025

What this trial tests

trial in HIV Nephropathy in 3,029 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 May 2018

Primary endpoint
31 January 2020

31 January 2030

Quick facts

Lead sponsor	King's College Hospital NHS Trust
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	3,029
Start date	1 May 2018
Primary completion	31 January 2020
Estimated completion	31 January 2030
Sites	1 location across United Kingdom

Conditions studied

• HIV Nephropathy — all drugs for HIV Nephropathy →
• Kidney Injury — all drugs for Kidney Injury →
• Kidney Diseases — all drugs for Kidney Diseases →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

King's College Hospital NHS Trust

Who can join

18 and older, any sex, with HIV Nephropathy or Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Associations between social determinants of health and comorbidity and multimorbidity in people of black ethnicities with HIV.
   Dominguez-Dominguez L, Campbell L, Barbini B, Fox J, et al · · 2024 · cited 11× · PMID 38265411 · DOI 10.1097/qad.0000000000003848
2. Waist circumference and cardiometabolic parameters in people of African/Caribbean ancestry with HIV in South London (CKD-AFRICA study).
   Cechin L, Dominguez-Dominguez L, Campbell L, Hamzah L, et al · · 2024 · cited 2× · PMID 38377277 · DOI 10.1177/09564624241233036
3. Mapping Vaccination Mindsets among UK Residents of Black Ethnicities with HIV: Lessons from COVID-19.
   Moon Z, Campbell L, Ottaway Z, Fox J, et al · · 2025 · cited 1× · PMID 40063203 · DOI 10.1007/s10461-025-04622-0
4. 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.
   Dominguez-Dominguez L, Hamzah L, Fox J, Vincent RP, et al · · 2025 · cited 1× · PMID 39791983 · DOI 10.1097/qai.0000000000003555
5. Cardiovascular disease risk in people of African ancestry with HIV in the United Kingdom.
   Ko S, Dominguez-Dominguez L, Ottaway Z, Campbell L, et al · · 2024 · cited 1× · PMID 39209512 · DOI 10.1111/hiv.13706