Clinical Trials


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

This study has been completed
University of Alabama at Birmingham


Information provided by (Responsible Party)
Nicholas Van Wagoner, MD, University of Alabama at Birmingham Identifier

First received: December 3, 2008
Last updated: June 14, 2017
Last Verified: June 2017
History of Changes


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
HIV Infections

Drug : Valacyclovir
Drug : Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

Further study details as provided by Nicholas Van Wagoner, MD, University of Alabama at Birmingham:

Primary Outcome Measures

  • Herpes Simplex Virus Type 2 Recurrence [ Time Frame: 24 Weeks ]
    Number of recurrences of genital herpes
  • CD4 Count [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    Number of participants with an HIV Viral Load of <500 copies/ml at 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.

Enrollment: 103
Study Start Date: January 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: There are no other names

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.



Ages Eligible for Study: 19 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00803543


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

Sponsors and Collaborators

University of Alabama at Birmingham


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

More Information

Responsible Party: Nicholas Van Wagoner, MD, Assistant Professor, University of Alabama at Birmingham Identifier: NCT00803543   History of Changes  
Other Study ID Numbers: F080718009  
Study First Received: December 3, 2008  
Last Updated: June 14, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by Nicholas Van Wagoner, MD, University of Alabama at Birmingham:

Herpes Simplex
HSV Type 2
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acyclovir processed this data on August 14, 2018
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