Clinical Evaluation of the Xpert® HIV-1 VL

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert HIV-1 VL Assay

Device

in vitro diagnostic test to quantify HIV-1 RNA

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jun 3, 2015
Registry last updated: Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed