Multi-Center Clinical Performance Evaluation of an Integrated Nucleic Acid Real Time Polymerase Chain Reaction (PCR) System for Quantitative Detection of Human Immunodeficiency Virus Type 1 (HIV-1) (Protocol #HIV-01-12)
Study on the Performance of an HIV-1 Quantitative Polymerase Chain Reaction (PCR) Assay System
Brief description of study.
The purpose of this study is to evaluate the clinical performance of the Beckman HIV-1 Quantitative PCR Assay System.
Detailed description of study
The purpose of this study is to evaluate the clinical performance of the Beckman HIV-1 Quantitative PCR Assay System.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV
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Age: 100 years or below
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Gender: All
This study investigates the clinical performance of an investigational assay system designed to measure the amount of HIV-1 in the blood. HIV-1 is a virus that attacks the immune system, leading to a condition known as AIDS. The assay system uses a technology called PCR, which stands for polymerase chain reaction, to detect and measure the virus.
Participants in the study will undergo procedures that involve collecting blood samples. These samples will be analyzed using the investigational assay system to determine its accuracy and reliability in measuring HIV-1 levels.
- Who can participate: Participants must be between the ages of 18 and 65 and must have a confirmed diagnosis of HIV-1. Additional eligibility criteria include stable antiretroviral therapy for at least six months prior to enrollment.
- Study details: Participants will have blood samples taken for analysis. The study involves using an investigational assay system to measure HIV-1 levels in these samples.
Interested in the study?
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