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Clinical Evaluation of the Xpert® HIV-1 VL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02461576
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):

Brief Summary:
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

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Study Type : Observational
Actual Enrollment : 966 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
Device: Xpert HIV-1 VL Assay
in vitro diagnostic test to quantify HIV-1 RNA

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females >18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy

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

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Responsible Party: Cepheid Identifier: NCT02461576     History of Changes
Other Study ID Numbers: 177B
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Cepheid:

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases