Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:15 - Any
Updated:2/24/2017
Start Date:January 2014
End Date:January 2017

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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

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.


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provided and not withdrawn (ie, subject has an evaluable sample in the study)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
We found this trial at
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New Orleans, Louisiana 70112
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Indianapolis, Indiana 46202
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Indianapolis, IN
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palm Springs, California 92262
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San Diego, California 92103
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Sarasota, Florida 34237
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Sarasota, FL
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