Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
This trial has been completed.
|Start date||January 2014|
|End date||February 2015|
|Trial size||468 participants|
|Trial identifier||NCT02026752, HIVQPS-US12-001, HIVQPS-US12-002, HIVQPS-US12-003, HIVQPS-US12-004|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Palm Springs, CA||Palmtree Clinical Research Inc||completed|
|San Diego, CA||UCSD - AnitViral Research Center (AVRC)||completed|
|New Haven, CT||Yale University||completed|
|Miami, FL||University of Miami - AIDS Clinical Research Unit||completed|
|Sarasota, FL||Community AIDS Network||completed|
|Indianapolis, IN||Wishard Health Services||completed|
|New Orleans, LA||Louisiana State University||completed|
|Baltimore, MD||Johns Hopkins University||completed|
|Bronx, NY||Jacobi Medical Center||completed|
Quantitative detection of HIV-1 RNA
time frame: single baseline visit
All participants at least 15 years old.
Inclusion Criteria - The subject has documented HIV infection - The subject is at least 15 years of age at the time of enrollment - For ART subjects, subject has documented HIV-1 RNA levels above the lower limit of quantitation of an FDA-approved assay in a sample collected in the past 90 days. - The subject (and/or legally authorized representative, if allowed) is willing and able to provide written informed consent before providing a specimen (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board [IRB]-approved waiver for parental consent for minors). Exclusion Criteria - A potential subject will be ineligible for the study if the subject, clinician, or medical record reports any of the following: - Subject's HIV disease stage and/or current ART status is unknown. - It is unknown if current or previous ART was changed or stopped due to therapy failure. - For non-ART subjects, subject was previously on ART in the past 30 days - Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study) - Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study - Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study
|Official title||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|
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