Clinical Evaluation of the Xpert® HIV-1 VL

Overview

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.

Full Title of Study: “Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: February 24, 2017

Interventions

  • Device: Xpert HIV-1 VL Assay
    • in vitro diagnostic test to quantify HIV-1 RNA

Arms, Groups and Cohorts

  • HIV-1 infected
    • 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

Clinical Trial Outcome Measures

Primary 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.

Participating in This Clinical Trial

Inclusion Criteria

  • HIV-1 seropositive adults using an FDA approved method – At least 18 years of age or older – Informed consent, if applicable Exclusion Criteria:

  • Subject is less than 18 years of age – Previously enrolled in this study – Samples not collected according to the procedure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cepheid
  • Provider of Information About this Clinical Study
    • Sponsor

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