Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

Completed

Conditions studied: Herpes Simplex Infections

In brief

This clinical performance study is being conducted to evaluate the performance of the Aptima Herpes Simplex Viruses 1 \& 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1) and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions. Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima swab collection kits will be evaluated.

Key facts

Study ID

NCT02270099

Run by

Hologic, Inc.

People needed

839

Starts

2014-12-01

Expected to finish

2017-06-01

Last updated by the study team

2017-08-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by HSV (as determined by the clinician)
• The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors)

You may not qualify if…

• The subject has only HSV lesions without exudates and cellular material
• The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment
• Subject already participated in this 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

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Sherif Khamis MD, Inc — Canoga Park, California, United States
• Mills Clinical Research — Los Angeles, California, United States
• Planned Parenthood of the Rocky Mountains — Denver, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Perimeter Institute for Clinical Research, Inc. (PICR Clinic) — Atlanta, Georgia, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• LSU Health Science Center — New Orleans, Louisiana, United States
• LSU Health Science Center - Shreveport — Shreveport, Louisiana, United States
• IRC Clinics — Towson, Maryland, United States
• University of Mississippi Medical Center/Crossroads Clinic (MSDH) — Jackson, Mississippi, United States
• Quality Clinical Research Inc. — Omaha, Nebraska, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Laboratory Corporation of America — Burlington, North Carolina, United States
• Westover Heights Clinic — Portland, Oregon, United States
• Planned Parenthood of Southeastern Pennsylvania — Philadelphia, Pennsylvania, United States
• Geneuity Clinical Research Services — Maryville, Tennessee, United States
• Planned Parenthood Gulf Coast, Inc. — Houston, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• American Regional University Pathologists — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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