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To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.
All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.
This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.
In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCHITECT HIV Ag/Ab Combo Specificity | Experimental | Specimens collected from normal apparently healthy individuals at low risk for HIV infection will be tested by the investigational HIV test and FDA-licensed HIV test. |
|
| ARCHITECT HIV Ag/Ab Combo Sensitivity | No Intervention | Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test. | |
| ARCHITECT HIV Ag/Ab Combo Reactivity | Experimental | Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARCHITECT HIV Ag/Ab Combo | Device | Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw. |
| Measure | Description | Time Frame |
|---|---|---|
| Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | 3 months |
| Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test. | 3 months |
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | 3 months |
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | 3 months |
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Normal Healthy Population:
Inclusion Criteria:
Exclusion Criteria:
Pregnant Female Population at Risk for HIV Infection:
Inclusion Criteria:
Exclusion Criteria:
HIV-1 Positive Pregnant Female Subjects
Inclusion Criteria:
Exclusion Criteria:
HIV-1 Positive Pediatric Subjects
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Roberts, MD | ARUP Laboratories | Principal Investigator |
| Laurence Demers, PhD | M.S. Hershey Medical Center | Principal Investigator |
| Fred Apple, PhD | Hennepin Healthcare Research Institute | Principal Investigator |
| Michael Loeffelholz, PhD | The University of Texas Medical Branch, Galveston | Principal Investigator |
| John Heffner | Clement J. Zablocki VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Phoenix | Arizona | 85013 | United States | ||
| Pinellas County Health Dept, Florida Department of Health |
All subjects were assigned to one group. There was no pre-screening criteria for this study.
All specimens collected under separate collection protocols or obtained from specimen suppliers: human immunodeficiency virus (HIV) antigen positive samples, HIV-1 antibody positive, specimens collected from individuals at risk for HIV infection in the United States (US), HIV-2 antibody positive and specimens collected from HIV-2 endemic area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Architect HIV Ag/Ab Combo Specificity | Specificity populations included: 6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy. 448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age. 588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age. Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| General Population From 16 to 89 Years |
|
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| ARCHITECT HIV Ag/Ab Combo | Device | Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible. |
|
| St. Petersburg |
| Florida |
| 33701 |
| United States |
| Springfield Clinic, LLP | Springfield | Illinois | 62703 | United States |
| Minneapolis Medical Research Foundation | Minneapolis | Minnesota | 55404 | United States |
| John T. Mather Memorial Hospital | Port Jefferson | New York | 117777 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| M.S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555-0609 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Planned Parenthood of Houston and Southeast Texas, Inc. | Houston | Texas | 77004 | United States |
| ARUP Laboratories | Salt Lake City | Utah | 84108-1221 | United States |
| Midwest Research Specialists, LLC | Milwaukee | Wisconsin | 53209 | United States |
| Clement J. Zablocki VA Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| FG001 | Architect HIV Ag/Ab Combo Sensitivity | Sensitivity populations included: 1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive. 67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing. 64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age). Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test. |
| FG002 | Architect HIV Ag/Ab Combo Reactivity | Reactivty populations included: 1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire. 203 specimen from pregnant females at risk for HIV infection. Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age. Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test. |
| COMPLETED |
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| NOT COMPLETED |
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| Pregnant Females Between 16-44 Years |
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| Pediatric From 2 to 21 Years |
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| ID | Title | Description |
|---|---|---|
| BG000 | Architect HIV Ag/Ab Combo Specificity | Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test. |
| BG001 | Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity | Specimens obtained from specimen vendors were tested with investigational HIV test. |
| BG002 | Architect Ag/Ab Combo HIV-1 Antibody Sensitivity | Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test. |
| BG003 | Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity | Specimens obtained from specimen vendors were tested with investigational HIV test. |
| BG004 | Architect HIV Ag/Ab Combo Reactivity | Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis. | Posted | Jul 2010 | Number | Blood Specimens | 3 months |
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| Primary | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test. | Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing. | Posted | Number | Blood specimens | 3 months |
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| Primary | Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females. | Posted | Number | Blood specimens | 3 months |
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| Primary | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area. | Posted | Jun 2010 | Number | Blood specimens | 3 months |
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| Secondary | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. | Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. | Posted | Number | Blood specimens | 3 months |
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Device adverse events were collected during the approximate 3 months of testing with Architect HIV Combo assay.
Adverse event reporting for follow-up collection (3) and subject's with specimens collected/tested during study (635)were under separate specimens collection protocol. Not applicable for specimens collected and banked or obtained from specimen venders and provided to testing site by Abbott.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Architect HIV Ag/Ab Combo Specificity | Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test. | 0 | 586 | 0 | 586 | ||
| EG001 | Architect HIV Ag/Ab Combo Sensitivity | Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test. | 0 | 0 | 0 | 0 | ||
| EG002 | Architect HIV Ag/Ab Combo Reactivity | Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test. | 0 | 55 | 0 | 55 |
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The principal investigator (PI) must provide copy of any proposed publication/presentation at least 30 days prior to submission for sponsor review/approval. PI must incorporate changes as the sponosr requires in order to protect the sponsor's proprietary rights and interests. Sponsor may require the PI to include acknowledgement of sponosr's role in the study. PI may be requested to delay publication/presentation an extra 60 days to enable sponor to secure patent or other proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Kaesdorf, Associate Director Clinical Affairs | Abbott Diagnostic Division | 847-937-8702 | barbara.kaesdorf@abbott.com |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| >= 21 years |
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| Not collected |
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| Male |
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| Not collected |
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| Côte D'Ivoire |
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| South Africa |
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| Cameroon |
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| HIV Ag/Ab Combo Nonreactive HIV status Negative |
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| Participants |
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| Participants |
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| OG002 | Reactivity in Pregnant Female Population | Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test. |
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