Clinical Evaluation of the Xpert® HIV-1 VL

Human Immunodeficiency Virus Clinical Trial

Official title:

Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461576
• Other study ID #: 177B
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: February 2, 2018
• Start date: July 2015
• Est. completion date: February 24, 2017

Study information

• Verified date: February 2018
• Source: Cepheid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: February 24, 2017
• Est. primary completion date: February 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cepheid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects	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.	1 day (A single time point)