Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Status Completed

Clinical Trial Summary

Clinical Trial Description

The purposes of this study are:

- To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);

- To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;

- To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.

We will evaluate the assays in diverse populations:

1. STD clinic population

2. Men who have sex with men, with high prevalence of HIV infection

3. Pregnant women

The study will inform the development of testing strategies:

1. Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)

2. Increase cutoff values to increase PPV

3. Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01112956
Study type	Observational
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	February 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06033261` - A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes	Phase 1/Phase 2
Completed	`NCT01132729` - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions	N/A
Completed	`NCT00362297` - Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2	Phase 4
Completed	`NCT01132716` - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions	N/A
Completed	`NCT03831165` - Melatonin Effects on Genital Herpes in Brazilian Women	Phase 4
Terminated	`NCT01658826` - Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes	Phase 2
Completed	`NCT00262106` - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection	Phase 3
Completed	`NCT01346475` - Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2	Phase 4
Completed	`NCT01390805` - Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)	N/A
Terminated	`NCT03146403` - Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection	Phase 2
Completed	`NCT03080961` - The VIBLOK SAfety and perFormancE Trial	N/A
Completed	`NCT00231049` - Trial Evaluating Safety, Tolerability and Immune Response of AG-707	Phase 1
Completed	`NCT00306787` - Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes	Phase 3
Completed	`NCT00477334` - Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients	Phase 4
Completed	`NCT00495573` - HSV-2 Shedding Resolution After Acyclovir Treatment	N/A
Not yet recruiting	`NCT03595995` - A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621	Phase 2
Completed	`NCT01281007` - Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes	Phase 3
Completed	`NCT00129818` - A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding	Phase 4
Completed	`NCT00808405` - GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women	N/A
Terminated	`NCT00495716` - Effect of HSV-2 Suppressive Therapy on Sexual Behavior	Phase 4