Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
- Conditions
- HIV-1 Infection
- Registration Number
- NCT02026752
- Lead Sponsor
- Gen-Probe, Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative detection of HIV-1 RNA single baseline visit Regression parameters (intercept and slope) will be estimated from method comparison analysis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Community AIDS Network
🇺🇸Sarasota, Florida, United States
University of Miami - AIDS Clinical Research Unit
🇺🇸Miami, Florida, United States
UCSD - AnitViral Research Center (AVRC)
🇺🇸San Diego, California, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Palmtree Clinical Research Inc
🇺🇸Palm Springs, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Wishard Health Services
🇺🇸Indianapolis, Indiana, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States