Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05685810
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-01-03
Brief Title:
Genetic Determinants of Kidney Disease in People of African Ancestry With HIV
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Genetic and Clinical Determinants of Cardiovascular Disease Diabetes Kidney Disease and Obesity in People of African Ancestry With HIV
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEN-AFRICA
Brief 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 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 obesitymetabolic syndrome cardiovascular disease and HIV immuno-virological and hepatitis BC co-infection status antiretroviral medications risk factors as well as additional genetic and epigenetic markers
Detailed Description:
At enrolment just over 3000 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 2350 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 andor 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 Kings College Hospital under their GEN-AFRICACKD-AFRICACoV-AFRICAOb-AFRICA study identifiers ID Samples collected as part of these protocols are labeled by study ID and stored in the James Black Building Kings 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
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 andor 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 Kings College Hospital under their GEN-AFRICACKD-AFRICACoV-AFRICAOb-AFRICA study identifiers ID Samples collected as part of these protocols are labeled by study ID and stored in the James Black Building Kings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None