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

NCT05977010 | Completed

• 1 other identifier: INA104.01
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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 \[Abbott\]

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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]

  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].

  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].

  From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ina-Respond: lead

Study Sites (1)

RSU Kabupaten Tangerang

Tangerang, West Java, 15111, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI

  Ina-Respond

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: August 4, 2023
• Study Start: January 8, 2018
• Primary Completion: January 10, 2018
• Study Completion: January 15, 2018
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)