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Active, Not Recruiting

NCT Number: NCT05685810

Genetic Determinants of Kidney Disease 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Nephropathy AIDS-Associated Nephropathy Blood-Borne Infections Body Weight Cardiovascular Diseases Communicable Diseases Diabetes Mellitus Disease Attributes Disease Susceptibility Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Predisposition to Disease Genital Diseases Glucose Metabolism Disorders HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Kidney Diseases Kidney Injury Lentivirus Infections Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital NHS Foundation Trust

London, SE5 9RJ, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Kidney disease

    Time frame: 2018-2030

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

Secondary outcomes

  1. Coronavirus disease (COVID-19)

    Time frame: 2020-2023

    Incidence and clinical and genetic determinants of COVID-19

  2. Multi-morbidity

    Time frame: 2019-2023

    Clinical and social determinants of multi-morbidity

  3. Weight change

    Time frame: 2013-2024

    Weight change in relation to antiretroviral exposures

  4. Obesity

    Time frame: 2013-2024

    Incidence of obesity in relation to antiretroviral exposures

  5. Dysglycaemia

    Time frame: 2019-2023

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

  6. Insulin resistance

    Time frame: 2019-2023

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

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • Africa Advocacy Foundation
  • Barts & The London NHS Trust
  • Brighton and Sussex University Hospitals NHS Trust
  • British HIV Association
  • Central and North West London NHS Foundation Trust
  • Chelsea and Westminster NHS Foundation Trust
  • Gilead Sciences
  • Guy's & St Thomas' Charity
  • Guy's and St Thomas' NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Lewisham and Greenwich NHS Trust
  • Manchester University NHS Foundation Trust
  • Medical Research Council
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • North Middlesex University Hospital NHS Trust
  • Royal Free Hospital NHS Foundation Trust
  • South Tees Hospitals NHS Foundation Trust
  • St George's Healthcare NHS Trust
  • The Leeds Teaching Hospitals NHS Trust
  • University of Cape Town
  • University of Pennsylvania
  • Vanderbilt University

Registry information

Official study title

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

Acronym: GEN-AFRICA

Important dates

Study start
2018
Primary completion
2020
Study completion
2030
First posted
Jan 17, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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