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

Completed

Conditions studied: HIV-1 Infection

In brief

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.

Key facts

Study ID

NCT02026752

Run by

Gen-Probe, Incorporated

People needed

468

Starts

2014-01-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-23

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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• Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)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

Where it is running

• Palmtree Clinical Research Inc — Palm Springs, California, United States
• UCSD - AnitViral Research Center (AVRC) — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami - AIDS Clinical Research Unit — Miami, Florida, United States
• Community AIDS Network — Sarasota, Florida, United States
• Wishard Health Services — Indianapolis, Indiana, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.