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

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]

Study Overview

• Status: Completed
• Conditions: HIV

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Tangerang, West Java, Indonesia, 15111
      • RSU Kabupaten Tangerang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population of this study is 58 HIV positive patients who are currently treated in Tangerang District Hospital. Sample size is calculated based on Bland-Altman methods and 95% Confidence Interval (CI) which will be used to evaluate agreement/concordance from mean difference between three methods.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the performance of three different methods in measuring HIV-1 VL.	HIV-1 RNA concentration (copies/ml) is determined from three different plasma viral load (pVL) measurement: Xpert® HIV-1 Viral Load [Cepheid], in-house qRT-PCR observing a conserved region in HIV-1 gag gene (HXB2 1849-1896) [primer/probes: Palmer S, Wiegand AP, Maldarelli F, et al. New real-time reverse transcriptase-initiated PCR assay with single-copy sensitivity for human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 2003 Oct;41(10):4531-6. doi: 10.1128/JCM.41.10.4531-4536.2003. PMID: 14532178; PMCID: PMC254331], and REALTIME HIV-1 VIRAL LOAD [Abbott].	From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6]	Mean difference of HIV-1 RNA concentration.	From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and REALTIME HIV-1 VIRAL LOAD [Abbott].	Mean difference of HIV-1 RNA concentration.	From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
To evaluate correlation and mean difference in HIV-1 pVL measurement using REALTIME HIV-1 VIRAL LOAD [Abbott] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6].	Mean difference of HIV-1 RNA concentration.	From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.

Collaborators and Investigators

• Sponsor: Ina-Respond
• Investigators: Principal Investigator: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI, Ina-Respond

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: INA104.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No