Trials / Completed
CompletedNCT02026752
Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
Collection of Plasma Samples From Human Immunodeficiency Virus (HIV) Type 1 (HIV-1) Infected Individuals for the Clinical Evaluation of the Aptima HIV-1 Quant Dx Assay
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 468 (actual)
- Sponsor
- Gen-Probe, Incorporated · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-02-01
- Completion
- 2017-01-01
- First posted
- 2014-01-03
- Last updated
- 2017-02-23
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02026752. Inclusion in this directory is not an endorsement.