Clinical Trials For Genital Herpes Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daily Valacyclovir in Reduction of HSV-2 Recurrence and Viral Shedding

Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daily Valacyclovir in the Reduction of HSV-2 Recurrence and Viral Shedding

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, November 2009

First Received: December 3, 2008   Last Updated: November 12, 2009   History of Changes

Sponsor:

University of Alabama at Birmingham

Collaborator:

GlaxoSmithKline

Information provided by:

University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00803543

Purpose

The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.


Condition

Intervention

HSV-2

HIV

HIV Infections

Drug: Valacyclovir

Drug: Placebo


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator)

Primary Purpose: Treatment

Official Title:

Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daiy Valacyclovir in the Reduction of HSV-2 Recurrences and Viral Shedding


Resource links provided by NLM:


MedlinePlus related topics: AIDS

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Alabama at Birmingham:


Primary Outcome Measures:

To evaluate efficacy of valacyclovir 1gm PO twice daily for the suppression of genital herpes in HIV/HSV-2 positive subjects receiving highly active antiretroviral therapy (HAART) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

To determine the prevalence of unrecognized genital HSV-2 infection in persons attending HIV care clinics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of valacyclovir in reducing HSV-2 viral shedding in HIV/HSV-2 positive subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of valacyclovir in reducing plasma HIV-1 RNA viral load in HIV-HSV-2 positive subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the safety of valacyclovir for the suppression of genital herpes in HIV/HSV-2 positive subjects. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:

134

Study Start Date:

January 2009

Estimated Study Completion Date:

December 2010

Estimated Primary Completion Date:

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

Arms

Assigned Interventions

Valacyclovir: Active Comparator

Drug: Valacyclovir

500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks

Placebo: Placebo Comparator

Drug: Placebo

Dosage: Two tablets once a day for 24 weeks


Detailed Description:

Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes “cold sores” or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.

Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.

Eligibility


Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

19 years or older

HSV-2 seropositive as determined by HerpeSelect-2 ELISA

Documented HIV-1 seropositive

Currently receiving HAART for 3 months or longer

CD4 count 350 or greater

Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD, diaphragm or cervical cap.

Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed

Exclusion Criteria:

History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.

Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.

Medical history of seizures

Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl

AST or ALT over 5 times uper limit of normal

History of thrombotic microangiopathy

For women, pregnancy as confirmed by a urine or serum pregnancy test.

Any other condition which, in the opinion of the principal investigator, may compromise the subject’s ability to follow study procedures and complete the study.

Participants with active bacterial STDs may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803543


Contacts

Contact: Suzette Byars, RN

205-975-9127

sbyars@uab.edu

Contact: Karen Savage, RN

205-975-7925

kgsavage@uab.edu


Locations

United States, Alabama

Community Care Building

Recruiting

Birmingham, Alabama, United States, 35294

Contact: Suzette Byars, RN     205-975-9127     sbyars@uab.edu

Contact: Karen Savage, RN     205-975-7925     kgsavage@uab.edu

Sponsors and Collaborators

University of Alabama at Birmingham

GlaxoSmithKline

Investigators

Principal Investigator:

Edward W Hook, III, M.D.

University of Alabama at Birmingham

More Information


No publications provided


Responsible Party:

University of Alabama at Birmingham ( Edward W. Hook, III, M.D. )

ClinicalTrials.gov Identifier:

NCT00803543 History of Changes

Other Study ID Numbers:

F080718009

Study First Received:

December 3, 2008

Last Updated:

November 12, 2009

Health Authority:

United States: Institutional Review Board


Keywords provided by University of Alabama at Birmingham:

HSV-2

Herpes Simplex

HSV Type 2

HIV

HIV/HSV

treatment experienced


Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Disease Attributes

Slow Virus Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

Antiviral Agents

Pharmacologic Actions

Recurrence

Immunologic Deficiency Syndromes

Valacyclovir

Virus Diseases

Acyclovir

Pathologic Processes

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010

Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daily Valacyclovir in the Reduction of HSV-2 Recurrence and Viral Shedding

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, November 2009

First Received: December 3, 2008   Last Updated: November 12, 2009   History of Changes

Sponsor:

University of Alabama at Birmingham

Collaborator:

GlaxoSmithKline

Information provided by:

University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00803543

Purpose

The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.


Condition

Intervention

HSV-2

HIV

HIV Infections

Drug: Valacyclovir

Drug: Placebo


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator)

Primary Purpose: Treatment

Official Title:

Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daiy Valacyclovir in the Reduction of HSV-2 Recurrences and Viral Shedding


Resource links provided by NLM:


MedlinePlus related topics: AIDS

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Alabama at Birmingham:


Primary Outcome Measures:

To evaluate efficacy of valacyclovir 1gm PO twice daily for the suppression of genital herpes in HIV/HSV-2 positive subjects receiving highly active antiretroviral therapy (HAART) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

To determine the prevalence of unrecognized genital HSV-2 infection in persons attending HIV care clinics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of valacyclovir in reducing HSV-2 viral shedding in HIV/HSV-2 positive subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of valacyclovir in reducing plasma HIV-1 RNA viral load in HIV-HSV-2 positive subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To evaluate the safety of valacyclovir for the suppression of genital herpes in HIV/HSV-2 positive subjects. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:

134

Study Start Date:

January 2009

Estimated Study Completion Date:

December 2010

Estimated Primary Completion Date:

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

Arms

Assigned Interventions

Valacyclovir: Active Comparator

Drug: Valacyclovir

500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks

Placebo: Placebo Comparator

Drug: Placebo

Dosage: Two tablets once a day for 24 weeks


Detailed Description:

Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes “cold sores” or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.

Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.

Eligibility


Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

19 years or older

HSV-2 seropositive as determined by HerpeSelect-2 ELISA

Documented HIV-1 seropositive

Currently receiving HAART for 3 months or longer

CD4 count 350 or greater

Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD, diaphragm or cervical cap.

Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed

Exclusion Criteria:

History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.

Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.

Medical history of seizures

Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl

AST or ALT over 5 times uper limit of normal

History of thrombotic microangiopathy

For women, pregnancy as confirmed by a urine or serum pregnancy test.

Any other condition which, in the opinion of the principal investigator, may compromise the subject’s ability to follow study procedures and complete the study.

Participants with active bacterial STDs may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803543


Contacts

Contact: Suzette Byars, RN

205-975-9127

sbyars@uab.edu

Contact: Karen Savage, RN

205-975-7925

kgsavage@uab.edu


Locations

United States, Alabama

Community Care Building

Recruiting

Birmingham, Alabama, United States, 35294

Contact: Suzette Byars, RN     205-975-9127     sbyars@uab.edu

Contact: Karen Savage, RN     205-975-7925     kgsavage@uab.edu

Sponsors and Collaborators

University of Alabama at Birmingham

GlaxoSmithKline

Investigators

Principal Investigator:

Edward W Hook, III, M.D.

University of Alabama at Birmingham

More Information


No publications provided


Responsible Party:

University of Alabama at Birmingham ( Edward W. Hook, III, M.D. )

ClinicalTrials.gov Identifier:

NCT00803543 History of Changes

Other Study ID Numbers:

F080718009

Study First Received:

December 3, 2008

Last Updated:

November 12, 2009

Health Authority:

United States: Institutional Review Board


Keywords provided by University of Alabama at Birmingham:

HSV-2

Herpes Simplex

HSV Type 2

HIV

HIV/HSV

treatment experienced


Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Disease Attributes

Slow Virus Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

Antiviral Agents

Pharmacologic Actions

Recurrence

Immunologic Deficiency Syndromes

Valacyclovir

Virus Diseases

Acyclovir

Pathologic Processes

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010