Clinical Trials For Genital Herpes Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

This study is currently recruiting participants.

Verified by Centers for Disease Control and Prevention, April 2010

First Received: October 13, 2009   Last Updated: April 28, 2010   History of Changes

Sponsor:

Centers for Disease Control and Prevention

Collaborators:

Massachusetts General Hospital

Johns Hopkins University

New York University School of Medicine

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT01112956

Purpose

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.


Condition

Genital Herpes


Study Type:

Observational

Study Design:

Observational Model: Cohort

Time Perspective: Prospective

Official Title:

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


Resource links provided by NLM:


MedlinePlus related topics: Herpes Simplex

U.S. FDA Resources


Further study details as provided by Centers for Disease Control and Prevention:


Primary Outcome Measures:

Sensitivity and Specificity using Western Blot as the Gold Standard test [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

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% [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]


Biospecimen Retention:   Samples Without DNA

Serum specimens


Estimated Enrollment:

2500

Study Start Date:

July 2009

Estimated Study Completion Date:

September 2011

Estimated Primary Completion Date:

September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

STD clinic patients

Patients attending sexually transmitted Disease clinics. If the initial testing result reported to the patient is confirmed by the Western Blot test, no follow-up specimens will be collected. If the initial testing result reported to the patient is different from the result by the Western Blot test, patients will be asked to provide a follow-up specimen 3-4 months after initial testing.

Pregnant women

Women recruited from prenatal clinic. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.

Men who have Sex with men (MSM)

Men recruited from a clinic for MSM with high risk for HIV infection. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.


Detailed 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:

STD clinic population

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

Pregnant women

The study will inform the development of testing strategies:

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

Increase cutoff values to increase PPV

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

Eligibility


Ages Eligible for Study:

16 Years to 55 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

The study population will comprise of diverse ethnic and racial populations derived from 3 Health and Human Services Regions and recruited from different type of clinics: 1) STD clinics 2) Prenatal clinic 3) Health clinic for gay men

Criteria

Inclusion Criteria:

Men and women 16-55 years of age

Exclusion Criteria:

Those who refuse to get tested for HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112956


Contacts

Contact: Fujie Xu, MD, PhD

404-639-1899

fax1@cdc.gov


Locations

United States, Maryland

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contact: Anne Rompalo, MD         arompalo@jhmi.edu

Contact: Hayley Mark         Hmark1@son.jhmi.edu

Principal Investigator: Anne Rompalo, MD

United States, Massachusetts

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contact: Donna Felsenstein, MD     617-726-3906     dfelsenstein@partners.org

Contact: Danielle Crochiere         DCROCHIER@PARTNERS.ORG

Principal Investigator: Donna Felsenstein, MD

Sub-Investigator: Laura Riley, MD

United States, New York

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contact: Demetre C Daskalakis, MD         demetre.daskalakis@med.nyu.edu

Principal Investigator: Demetre C daskalakis, MD

Sponsors and Collaborators

Centers for Disease Control and Prevention

Massachusetts General Hospital

Johns Hopkins University

New York University School of Medicine

Investigators

Principal Investigator:

Donna Felsenstein, MD

Massachusetts General Hospital

More Information


No publications provided


Responsible Party:

CDC ( Fujie Xu/Epidemiologist )

ClinicalTrials.gov Identifier:

NCT01112956 History of Changes

Other Study ID Numbers:

CDC-NCHHSTP-1127

Study First Received:

October 13, 2009

Last Updated:

April 28, 2010

Health Authority:

United States: Federal Government


Keywords provided by Centers for Disease Control and Prevention:

HSV-2

HSV-1

Sensitivity

Specificity

Testing algorithm

Test evaluation


Additional relevant MeSH terms:

Skin Diseases, Viral

Genital Diseases, Female

Virus Diseases

Herpes Simplex

Skin Diseases, Infectious

Sexually Transmitted Diseases, Viral

Skin Diseases

Herpes Genitalis

Sexually Transmitted Diseases

DNA Virus Infections

Genital Diseases, Male

Herpesviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010

Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

This study is currently recruiting participants.

Verified by Centers for Disease Control and Prevention, April 2010

First Received: October 13, 2009   Last Updated: April 28, 2010   History of Changes

Sponsor:

Centers for Disease Control and Prevention

Collaborators:

Massachusetts General Hospital

Johns Hopkins University

New York University School of Medicine

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT01112956

Purpose

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.


Condition

Genital Herpes


Study Type:

Observational

Study Design:

Observational Model: Cohort

Time Perspective: Prospective

Official Title:

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


Resource links provided by NLM:


MedlinePlus related topics: Herpes Simplex

U.S. FDA Resources


Further study details as provided by Centers for Disease Control and Prevention:


Primary Outcome Measures:

Sensitivity and Specificity using Western Blot as the Gold Standard test [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

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% [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]


Biospecimen Retention:   Samples Without DNA

Serum specimens


Estimated Enrollment:

2500

Study Start Date:

July 2009

Estimated Study Completion Date:

September 2011

Estimated Primary Completion Date:

September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

STD clinic patients

Patients attending sexually transmitted Disease clinics. If the initial testing result reported to the patient is confirmed by the Western Blot test, no follow-up specimens will be collected. If the initial testing result reported to the patient is different from the result by the Western Blot test, patients will be asked to provide a follow-up specimen 3-4 months after initial testing.

Pregnant women

Women recruited from prenatal clinic. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.

Men who have Sex with men (MSM)

Men recruited from a clinic for MSM with high risk for HIV infection. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.


Detailed 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:

STD clinic population

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

Pregnant women

The study will inform the development of testing strategies:

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

Increase cutoff values to increase PPV

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

Eligibility


Ages Eligible for Study:

16 Years to 55 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

The study population will comprise of diverse ethnic and racial populations derived from 3 Health and Human Services Regions and recruited from different type of clinics: 1) STD clinics 2) Prenatal clinic 3) Health clinic for gay men

Criteria

Inclusion Criteria:

Men and women 16-55 years of age

Exclusion Criteria:

Those who refuse to get tested for HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112956


Contacts

Contact: Fujie Xu, MD, PhD

404-639-1899

fax1@cdc.gov


Locations

United States, Maryland

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contact: Anne Rompalo, MD         arompalo@jhmi.edu

Contact: Hayley Mark         Hmark1@son.jhmi.edu

Principal Investigator: Anne Rompalo, MD

United States, Massachusetts

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contact: Donna Felsenstein, MD     617-726-3906     dfelsenstein@partners.org

Contact: Danielle Crochiere         DCROCHIER@PARTNERS.ORG

Principal Investigator: Donna Felsenstein, MD

Sub-Investigator: Laura Riley, MD

United States, New York

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contact: Demetre C Daskalakis, MD         demetre.daskalakis@med.nyu.edu

Principal Investigator: Demetre C daskalakis, MD

Sponsors and Collaborators

Centers for Disease Control and Prevention

Massachusetts General Hospital

Johns Hopkins University

New York University School of Medicine

Investigators

Principal Investigator:

Donna Felsenstein, MD

Massachusetts General Hospital

More Information


No publications provided


Responsible Party:

CDC ( Fujie Xu/Epidemiologist )

ClinicalTrials.gov Identifier:

NCT01112956 History of Changes

Other Study ID Numbers:

CDC-NCHHSTP-1127

Study First Received:

October 13, 2009

Last Updated:

April 28, 2010

Health Authority:

United States: Federal Government


Keywords provided by Centers for Disease Control and Prevention:

HSV-2

HSV-1

Sensitivity

Specificity

Testing algorithm

Test evaluation


Additional relevant MeSH terms:

Skin Diseases, Viral

Genital Diseases, Female

Virus Diseases

Herpes Simplex

Skin Diseases, Infectious

Sexually Transmitted Diseases, Viral

Skin Diseases

Herpes Genitalis

Sexually Transmitted Diseases

DNA Virus Infections

Genital Diseases, Male

Herpesviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010