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

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HSV-2, Herpes Simplex, HSV Type 2, HIV, HIV/HSV, treatment experienced

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Community Care Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Valacyclovir

Placebo

Arm Description

This is the arm taking Valacyclovir

This is the arm taking the placebo

Outcomes

Primary Outcome Measures

Herpes Simplex Virus Type 2 Recurrence
Number of recurrences of genital herpes
CD4 Count
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Number of Participants With an HIV Viral Load of <500 Copies/ml
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2008
Last Updated
June 14, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00803543
Brief Title
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HSV-2, Herpes Simplex, HSV Type 2, HIV, HIV/HSV, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valacyclovir
Arm Type
Active Comparator
Arm Description
This is the arm taking Valacyclovir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This is the arm taking the placebo
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Other Intervention Name(s)
There are no other names
Intervention Description
500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
There are no other names
Intervention Description
Dosage: Two tablets once a day for 24 weeks
Primary Outcome Measure Information:
Title
Herpes Simplex Virus Type 2 Recurrence
Description
Number of recurrences of genital herpes
Time Frame
24 Weeks
Title
CD4 Count
Description
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Time Frame
24 weeks
Title
Number of Participants With an HIV Viral Load of <500 Copies/ml
Description
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Time Frame
24 weeks
Title
Rate of Asymptomatic HSV-2 Genital Shedding
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Van Wagoner, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Care Building
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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