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

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 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Genital Herpes HIV/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 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Valacyclovir	Drug: Valacyclovir 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo Comparator: Placebo	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: Nicholas Van Wagoner, MD	205-934-5191	nvw@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: Nicholas Van Wagoner, MD 205-934-5191 nvw@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:	Edward W. Hook, III, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00803543 History of Changes
Other Study ID Numbers:	F080718009
Study First Received:	December 3, 2008
Last Updated:	August 5, 2011
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Recurrence
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012