Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Genital Herpes Clinical Trial

Official title:

Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112956
• Other study ID #: CDC-NCHHSTP-1127
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: March 22, 2011
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men and women 16-55 years of age

Exclusion Criteria:

• Those who refuse to get tested for HIV

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis
• Herpes Simplex

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New York University School of Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Johns Hopkins University, Massachusetts General Hospital, New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity using Western Blot as the Gold Standard test		Up to 4 months after initial testing	No
Secondary	In population with relative low prevalence of HSV-2 infection (e.g. persons <=25 years), whether a combination of tests (i.e. testing algorithm(s)) can increase the positive predictive value to the level of >= 95%		Up to 4 months after initial testing	No