Status:
COMPLETED
Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Herpes Simplex Virus
Eligibility:
FEMALE
19+ years
Brief Summary
PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and nonpregnant women) and wi...
Detailed Description
The GeneXpert HSV PCR test will be validated against HSV viral cultures and routine quantitative PCR. Validation will occur in two populations: 1) nonpregnant women in STI clinics with clinically-appa...
Eligibility Criteria
Inclusion
- •Signed Informed Consent from woman
- •≥ 19 years of age
- Female gender
- In active labor with a viable fetus, OR non-pregnant and being evaluated in STI clinics for herpetic genital lesions
Exclusion
- •For women in active labor, active herpetic lesions in the genital region
- Receipt of acyclovir, valacyclovir, or famciclovir within the previous 14 days
- Known HIV infection
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
12550 Patients enrolled
Trial Details
Trial ID
NCT01878383
Start Date
January 1 2014
End Date
December 31 2019
Last Update
September 9 2020
Active Locations (15)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
3
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, United States, 80045
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010