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NCT02026752 · ClinicalTrials.gov registry record
Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
A clinical trial, sponsored by Gen-Probe, Incorporated.
- Completed
- Registry status
- 468
- Enrollment target
NCT02026752: Completed study, sponsored by Gen-Probe, Incorporated.
NCT02026752 is a clinical trial that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 468 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02026752 has completed, sponsored by Gen-Probe, Incorporated.
- COMPLETED
- Registry status
- 468 participants
- Enrollment target
Study 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.
Primary Outcome
Regression parameters (intercept and slope) will be estimated from method comparison analysis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-01 |
What the finished NCT02026752 record still lists
NCT02026752 is an observational study that tracks outcomes without assigning an intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02026752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02026752 about?
NCT02026752 is a clinical study titled "Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay". 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 o...
What is the current status of trial NCT02026752?
This trial is currently completed. The enrollment target is 468 participants. The study started on 2014-01. Estimated completion is 2017-01.
Who is sponsoring clinical trial NCT02026752?
This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
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