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

June 14, 2017 updated by: Nicholas Van Wagoner, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Community Care Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Valacyclovir
This is the arm taking Valacyclovir
Drug: Valacyclovir
500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Other Names:
  • There are no other names
PLACEBO_COMPARATOR: Placebo
This is the arm taking the placebo
Drug: Placebo
Dosage: Two tablets once a day for 24 weeks
Other Names:
  • There are no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Herpes Simplex Virus Type 2 Recurrence
Time Frame: 24 Weeks
Number of recurrences of genital herpes
24 Weeks
CD4 Count
Time Frame: 24 weeks
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
24 weeks
Number of Participants With an HIV Viral Load of <500 Copies/ml
Time Frame: 24 weeks
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding
Time Frame: 24 weeks
Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Nicholas Van Wagoner, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (ESTIMATE)

December 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F080718009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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