Clinical Evaluation of the Xpert® HIV-1 VL

Cepheid

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Device: Xpert HIV-1 VL Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT02461576

177B

Details and patient eligibility

About

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.

Enrollment: 966 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

966 participants in 1 patient group

HIV-1 infected

Description:

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

Treatment:

Device: Xpert HIV-1 VL Assay