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

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ClinicalTrials.gov Identifier: NCT00803543
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nicholas Van Wagoner, MD, University of Alabama at Birmingham

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV HIV Infections Drug: Valacyclovir Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Outcome Measures
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Primary Outcome Measures :
  1. Herpes Simplex Virus Type 2 Recurrence [ Time Frame: 24 Weeks ]
    Number of recurrences of genital herpes

  2. CD4 Count [ Time Frame: 24 weeks ]
    CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml

  3. 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

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803543


Locations
United States, Alabama
Community Care Building
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: Nicholas Van Wagoner, MD University of Alabama at Birmingham
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nicholas Van Wagoner, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00803543     History of Changes
Other Study ID Numbers: F080718009
First Posted: December 5, 2008    Key Record Dates
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nicholas Van Wagoner, MD, University of Alabama at Birmingham:
HSV-2
Herpes Simplex
HSV Type 2
 HIV
HIV/HSV
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Recurrence
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents