HIVProXpertNCT05977010
Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count
An observational study of HIV, run by Ina-Respond at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 58 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Jan 2018to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Suffered from a disease or having condition that could complicated the blood drawing process or increasing the risk of disease complications.
- Currently imprisoned.
Trial locations and contacts
1 site in 1 country.
About this study
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]
Read the 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.
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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]
Mean difference of HIV-1 RNA concentration.
Measured: 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.
Measured: 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.
Measured: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start8 Jan 2018
- Primary completion10 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI, Principal investigator, Ina-Respond
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977010
- Sponsor's protocol ID
- INA104.01
- Acronym
- ProXpert
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2018
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count
- ClinicalTrials.gov ID
- NCT05977010
- Acronym / sponsor ID
- ProXpert / INA104.01
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Suffered from a disease or having condition that could complicated the blood drawing process or increasing the risk of disease complications.
- Currently imprisoned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the performance of three different methods in measuring HIV-1 VL.
Time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
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].
3 secondary outcomes
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]
Time frame: 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].
Time frame: 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].
Time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI principal investigator
Ina-Respond
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Ina-Respond at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the performance of three different methods in measuring HIV-1 VL. (time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.