Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol
NCT ID: NCT04971343
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
8650 participants
OBSERVATIONAL
2019-12-04
2022-09-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HIV Vaccine Study in HIV Positive Patients
NCT01071031
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
NCT05719441
Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
NCT00073216
Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV
NCT03837756
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
NCT00514605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All samples collected will be anonymized or pseudo-anonymized, leftover, remnant samples. pseudo-anonymized collection of samples will required oral patient consent documented in their medical record or electronic case report form (eCRF). For CE marking, below is the number of samples that will be included per group :
* Unselected blood donors : 6,000 fresh samples (requirements CTS : 5,000)
* Hospitalized patients : 1,200 frozen samples and 800 fresh samples (requirements CTS : 200)
* Known HIV-1 Ab positive : 470 frozen samples and 30 fresh samples (requirements CTS : 400)
* Known HIV-2 Ab positive : 100 frozen samples (requirements CTS : 100)
* Known acute HIV-1 p24 Ag positive : 50 frozen samples (requirements CTS : 50)
The following additional design requirements will be incorporated to EU study to satisfy Canadian regulations, but additional data generated on the additional samples will not be used for CE-marking:
* Collection and testing of 4,000 additional blood donor samples. Blood donors' samples should include 300 blood donor matched fresh plasma and serum samples
* Distribution of blood donor sample testing equally over three (3) blood donor sites, using 3 different lots of reagents
* Retesting of 1000 blood donor samples internally with 1 lot close to expiration
* Collection and testing of maximum 210 additional p24 Ag positive sample beyond the 50 required by CTS
* Distribution of p24 Ag and HIV-1 Ab positive sample testing equally over three (3) testing sites, using 3 different lots of reagents.
Additional Canadian requirements will be covered by US protocol(s) and Verification and validation protocols.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Unselected blood donors
Access HIV_blood donor
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo .
* All initially reactive specimen results will be tested in duplicate per IFU .
* All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Access HIV_Canada's requirements_Blood donor
To fit with Canada's requirements:
* 4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples.
* Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements
Hospitalized patients
Access HIV_Hospitalized patient
All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient.
* All initially reactive specimen results will be tested in duplicate per IFU .
* All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Known HIV-1 Ab positive
Access HIV_known HIV-1 antibody positives
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay .
* All initially reactive specimen results will be tested in duplicate per IFU .
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis
Access HIV_Canada's requirements_HIV positive
To fit with Canada's requirements:
o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
Known HIV-2 Ab positive
Access HIV_known HIV-2 antibody positives
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay.
* All initially reactive specimen results will be tested in duplicate per IFU .
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
Access HIV_Canada's requirements_HIV positive
To fit with Canada's requirements:
o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
Known Acute HIV-1 p24 Ag positive
Access HIV_known HIV-1 p24 Ag positive
All samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay.
* Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay.
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays
Access HIV_Canada's requirements_HIV positive
To fit with Canada's requirements:
o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
Access HIV_Canada's requirements_P24 Positive
To fit with Canada's requirements:
* HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
* Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Access HIV_blood donor
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo .
* All initially reactive specimen results will be tested in duplicate per IFU .
* All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Access HIV_Hospitalized patient
All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient.
* All initially reactive specimen results will be tested in duplicate per IFU .
* All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Access HIV_known HIV-1 antibody positives
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay .
* All initially reactive specimen results will be tested in duplicate per IFU .
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis
Access HIV_known HIV-2 antibody positives
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay.
* All initially reactive specimen results will be tested in duplicate per IFU .
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
Access HIV_known HIV-1 p24 Ag positive
All samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay.
* Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay.
* For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays
Access HIV_Canada's requirements_Blood donor
To fit with Canada's requirements:
* 4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples.
* Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements
Access HIV_Canada's requirements_HIV positive
To fit with Canada's requirements:
o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
Access HIV_Canada's requirements_P24 Positive
To fit with Canada's requirements:
* HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
* Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males or females
* Aged ≥18 years of age
* Belonging to one of the following enrollment groups:
* Unselected blood donor
* Hospitalized patient
* Known HIV-1 antibody positive patients
* confirmed positive by Immunoblot, Western blot or HIV-1/HIV-2 antibody differentiation test either at time of enrollment vai same study draw or historically from medical record
* Known HIV-2 antibody positive patients
* confirmed HIV-2 positive by BioPlex 2200 HIV Ag-Ab Assay
* Known HIV-1 Ag positive patients
* For samples from HIV seroconversion panels
* Tested during EU HIV clinical trial: confirmed positive by screening HIV Ag/Ab combo positive for p24 Ag, and p24 Ag screening test positive (result from CoA or additional testing)
* Tested as part of seroconversion panel studies (V\&V studies): First sample of the panel that is ARCHITECT Ag/Ab combo assay positive or BioPlex 2200 HIV Ag-Ab Assay p24 positive, and p24 Ag test positive (result from CoA or additional R\&D testing)
* For routine clinical samples:
* Confirmed positive by screening HIV Ag/Ab combo assay positive for p24 Ag , and p24 Ag test positive by confirmatory test, or
* Confirmed positive by screening HIV Ag/Ab combo assay HIV positive, and p24 Ag test positive by confirmatory test and PCR HIV POS and IB/WB HIV negative or indetermined.
* with at least 2.0 mL leftover EDTA plasma sample from hospitalized patients OR
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beckman Coulter, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, , France
Eurofins Biomnis
Ivry-sur-Seine, , France
Qbd, Efs Hfno
Loos, , France
UPR Lille, Établissement français du sang Hauts-de-France - Normandie
Loos, , France
Laboratoire de Virologie, Laboratoire associé au CNR du VIH
Rouen, , France
Cerba Xpert
Saint-Ouen-l'Aumône, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC-TR18-0410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.