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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803543
• Other study ID #: F080718009
• Status: Completed
• Phase: N/A
• First received: December 3, 2008
• Last updated: December 2, 2014
• Start date: January 2009
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections
• HSV-2

Intervention

Drug:
• Valacyclovir
500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
• Placebo
Dosage: Two tablets once a day for 24 weeks

Locations

Country	Name	City	State
United States	Community Care Building	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		24 Weeks	No
Primary	To determine the prevalence of unrecognized genital HSV-2 infection in persons attending HIV care clinics		24 weeks	No
Primary	To evaluate the efficacy of valacyclovir in reducing HSV-2 viral shedding in HIV/HSV-2 positive subjects		24 weeks	No
Primary	To evaluate the efficacy of valacyclovir in reducing plasma HIV-1 RNA viral load in HIV-HSV-2 positive subjects		24 weeks	No
Primary	To evaluate the safety of valacyclovir for the suppression of genital herpes in HIV/HSV-2 positive subjects.		24 weeks	No