Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding

NCT ID: NCT00803543

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-04-30

Brief 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.

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.

Conditions

HIV; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Valacyclovir

This is the arm taking Valacyclovir

Group Type: ACTIVE_COMPARATOR

Valacyclovir

Intervention Type: DRUG

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

Placebo

This is the arm taking the placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage: Two tablets once a day for 24 weeks

Interventions

Valacyclovir

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

Intervention Type: DRUG

Placebo

Dosage: Two tablets once a day for 24 weeks

Intervention Type: DRUG

Other Intervention Names

There are no other names; There are no other names

Eligibility Criteria

Inclusion Criteria

• 19 years or older
• HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
• Documented HIV-1 seropositive
• Currently receiving HAART for 3 months or longer
• CD4 (cluster of differentiation 4) 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 (intrauterine device), 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 (aspartate aminotransferase) or ALT (alanine aminotransferase) 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 (sexually transmitted diseases) may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Van Wagoner, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Van Wagoner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Community Care Building

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F080718009

Identifier Type: -

Identifier Source: org_study_id