Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977010
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2018-01-11
Brief Title:
Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count
Sponsor:
Ina-Respond
Organization:
Ina-Respond
Study Overview
Official Title:
Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count
Status:
COMPLETED
Status Verified Date:
2023-07
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:
ProXpert
Brief Summary:
This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital The participant will be interviewed and retrieved for their demographics treatment history CD4 and viral load history Blood will be drawn for HIV-1 viral load examination using Xpert HIV-1 Viral Load Cepheid in-house qRT-PCR and REALTIME HIV-1 VIRAL LOAD Abbott
Detailed Description:
Participant candidate will be screened at Tangerang District Hospitals outpatient and inpatient units The purpose is to get various VL values from participants with various clinical conditions light-heavy If a participant is willing to participate and has signed the Informed Consent Form ICF heshe will be interviewed for demographic data and case history age gender first HIV diagnosis After that the participant will be physically examined height weight and vital signs Other information such as current HIV clinical stage current ART regimen Viral Load value final and highest and CD4 final and lowest are collected from participants medical records
The participants blood will be drawn as much as 9 ml and will be processed to obtain plasma Plasma will be aliquoted into 3 vials for VL test using 3 devices 1 ml using Xpert HIV-1 1 ml using PCR Abbott at Dharmais Hospital and 1 ml or leftover plasma using PCR ABI7500 at INA-RESPONDs reference laboratory The process follows the manufacturers manual or the standard of sample preparation procedure and the operation of the devices at each hospital
The result of viral load measurement will be informed to the participant via the attending physician during the participants routine HIV treatment visit to the hospital
The participants blood will be drawn as much as 9 ml and will be processed to obtain plasma Plasma will be aliquoted into 3 vials for VL test using 3 devices 1 ml using Xpert HIV-1 1 ml using PCR Abbott at Dharmais Hospital and 1 ml or leftover plasma using PCR ABI7500 at INA-RESPONDs reference laboratory The process follows the manufacturers manual or the standard of sample preparation procedure and the operation of the devices at each hospital
The result of viral load measurement will be informed to the participant via the attending physician during the participants routine HIV treatment visit to the hospital
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