- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971343
Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol (HIV-EU-11-18)
Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol
Study Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: Access HIV_blood donor
- Diagnostic test: Access HIV_Canada's requirements_Blood donor
- Diagnostic test: Access HIV_Hospitalized patient
- Diagnostic test: Access HIV_known HIV-1 antibody positives
- Diagnostic test: Access HIV_Canada's requirements_HIV positive
- Diagnostic test: Access HIV_known HIV-2 antibody positives
- Diagnostic test: Access HIV_known HIV-1 p24 Ag positive
- Diagnostic test: Access HIV_Canada's requirements_P24 Positive
Detailed Description
The study will involve a multicenter, prospective and retrospective sample collection, and testing of samples with the investigational HIV assay as required per the EU Common Technical Specification (CTS). The CTS requires testing of samples from blood donors, hospitalized patients, known HIV-1 Ab positive patients, known HIV-2 Ab positive patients, and known HIV-1 p24 Ag positive patients. Any retrospectively collected samples will meet all inclusion/exclusion criteria.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bois-Guillaume, France, 76232
- Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
-
Ivry-sur-Seine, France, 94208
- Eurofins Biomnis
-
Loos, France, 59373
- UPR Lille, Établissement français du sang Hauts-de-France - Normandie
-
Rouen, France, 76031
- Laboratoire de Virologie, Laboratoire associé au CNR du VIH
-
Saint-Ouen-l'Aumône, France, 95310
- Cerba Xpert
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The test population includes :
- 6,000 unselected blood donors sample
- 2,000 hospitalized patients
- 500 Known HIV-1 Ab positive
- 100 Known HIV-2 Ab positive
- 50 Known acute HIV-1 p24 Ag positive
Description
Inclusion Criteria:
Anonymized or pseudo-anonymized leftover samples from
- 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
- at least 1.5 mL leftover EDTA plasma or serum sample from blood donors or known HIV-1 antibody positive patients, with confirmatory test already done as per inclusion criteria OR
- at least 1.0 mL leftover EDTA plasma or serum sample from known p24 Ag positive patients or known HIV-2 antibody positive patients, with confirmatory test already done as per inclusion criteria
Exclusion Criteria:
- Samples from subjects already included in the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Unselected blood donors
|
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 .
To fit with Canada's requirements:
|
Hospitalized patients
|
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.
|
Known HIV-1 Ab positive
|
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 .
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 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
|
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. 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.
|
Known Acute HIV-1 p24 Ag 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. 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.
To fit with Canada's requirements:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity
Time Frame: Baseline
|
Sensitivity and specificity relative to the final patient HIV infection status determined from confirmatory testing will be calculated.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC-TR18-0410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV I Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
University of ConnecticutMedical Research Council, South AfricaRecruitingHIV I InfectionUnited States
-
Hospital Civil de GuadalajaraCompleted
-
State University of New York - Downstate Medical...National Institute of Mental Health (NIMH); Yale UniversityEnrolling by invitationHIV I InfectionUnited States
-
Bionor Immuno ASCompletedHIV I InfectionGermany, United States, Spain, United Kingdom, Italy
-
Bionor Immuno ASCelgene CorporationCompleted
-
Biomedical Research and Training Institute, ZimbabweGilead SciencesCompletedHIV I Infection | ARTZimbabwe
-
Vir Biotechnology, Inc.National Institute of Allergy and Infectious Diseases (NIAID); HIV Vaccine...RecruitingHIV I InfectionUnited States, South Africa
Clinical Trials on Access HIV_blood donor
-
Yonsei UniversityCompleted
-
Laura KairThe Gerber Foundation; Children's Miracle NetworkCompletedExclusive Breastfeeding | Breastfeeding Duration | Donor Milk SupplementationUnited States
-
AC Camargo Cancer CenterCompletedCancer | Catheter ComplicationsBrazil
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruitingTransradial AccessChina
-
University Hospitals Cleveland Medical CenterNot yet recruiting
-
C. R. BardTerminatedVascular Access ComplicationUnited States
-
University of PatrasUnknownArterial Access in Percutaneous Coronary Angiography or InterventionGreece
-
Hugo W. Moser Research Institute at Kennedy Krieger...CompletedSpinal Cord InjuryUnited States
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Acibadem UniversityCompleted