Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count (ProXpert)

Ina-Respond

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: Other

Identifiers

NCT05977010

INA104.01

Details and patient eligibility

About

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]

Full description

Participant candidate will be screened at Tangerang District Hospital's 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), he/she 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 participant's medical records.

The participant's 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-RESPOND's reference laboratory. The process follows the manufacturer's 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 participant's routine HIV treatment visit to the hospital.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV positive patient by the HIV Diagnoses Guideline in the Tangerang District Hospital.
• Patient older than 18 years and above.
• Willing and signed the informed consent (ICF).
• Willing to comply with the study procedures.

Exclusion criteria

• Suffered from a disease or having condition that could complicated the blood drawing process or increasing the risk of disease complications.
• Currently imprisoned.