Clinical Evaluation of the Xpert® HIV-1 VL

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT02461576
• Lead Sponsor: Cepheid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Study Start: 2015-07
• Primary Completion: 2017-02-24
• Study Completion: 2017-02-24
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 966

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects	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.