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



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2014
End Date:June 2016

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Clinical Evaluation of the Aptima® Herpes Simplex Viruses 1 & 2 Assay on the Panther® System in Swab Specimens From Symptomatic Subjects Presenting With a Suspected Herpes Lesion(s)

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 in the male anogenital region, the female anogenital region, the oral cavity and
other mucomembranous or mucocutaneous areas of the face (oral/facial), and the skin.
Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima
swab collection kits will be evaluated.


Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
We found this trial at
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Shreveport, Louisiana 71103
Principal Investigator: John Vanchiere, MD, PhD
Phone: 318-675-6081
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jane Schwebke, MD
Phone: 205-975-5665
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Boise, Idaho
Principal Investigator: Mark Turner, MD
Phone: 208-377-8653
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Burlington, North Carolina 27215
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Canoga Park, California 91306
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Houston, Texas 77023
Principal Investigator: Paul Fine, MD
Phone: 713-831-6553
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Kenneth Fife, MD
Phone: 317-274-8115
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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884 Lakeland Drive
Jackson, Mississippi 39216
Principal Investigator: Leandro Mena, MD
Phone: 601-984-5560
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Los Angeles, California 90069
Principal Investigator: Anthony Mills, MD
Phone: 310-550-2271
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Maryville, Tennessee 37804
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New Haven, Connecticut 06520
Principal Investigator: Michael Kozal, MD
Phone: 203-737-4040
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New Orleans, Louisiana 70112
Principal Investigator: Stephanie N Taylor, MD
Phone: 504-568-4132
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Principal Investigator: Michael Dunn, MD
Phone: 402-934-0044
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Philadephia, Pennsylvania 19107
Principal Investigator: Joel Lebed, DO
Phone: 267-514-2098
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Phoenix, Arizona 85018
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Portland, Oregon 97210
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Rochester, New York 14609
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Salt Lake City, Utah 84108
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Towson, Maryland 21204
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Webster, Texas 77598
Principal Investigator: Stephen Tyring, MD
Phone: 281-333-2288
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