Status:
COMPLETED
Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
Lead Sponsor:
Hologic, Inc.
Conditions:
Herpes Simplex Infections
Eligibility:
All Genders
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
839 Patients enrolled
Trial Details
Trial ID
NCT02270099
Start Date
December 1 2014
End Date
June 1 2017
Last Update
August 14 2017
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
3
Sherif Khamis MD, Inc
Canoga Park, California, United States, 91303
4
Mills Clinical Research
Los Angeles, California, United States, 90069