Clinical Evaluation of the Xpert® HIV-1 VL
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|ClinicalTrials.gov Identifier: NCT02461576|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.
|Condition or disease||Intervention/treatment|
|Human Immunodeficiency Virus||Device: Xpert HIV-1 VL Assay|
|Study Type :||Observational|
|Actual Enrollment :||966 participants|
|Official Title:||Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||February 24, 2017|
|Actual Study Completion Date :||February 24, 2017|
this is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals
Device: Xpert HIV-1 VL Assay
in vitro diagnostic test to quantify HIV-1 RNA
Primary Outcome Measures :
- Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects [ Time Frame: 1 day (A single time point) ]This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.
Biospecimen Retention: Samples With DNA
Leftover plasma specimens will be retained in a biobank.
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