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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803543
First Posted: December 5, 2008
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nicholas Van Wagoner, MD, University of Alabama at Birmingham
December 3, 2008
December 5, 2008
July 11, 2015
July 13, 2017
July 13, 2017
January 2009
April 2014   (Final data collection date for primary outcome measure)
  • 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.
  • To evaluate efficacy of valacyclovir 1gm PO twice daily for the suppression of genital herpes in HIV/HSV-2 positive subjects receiving highly active antiretroviral therapy (HAART) [ Time Frame: 24 Weeks ]
  • To determine the prevalence of unrecognized genital HSV-2 infection in persons attending HIV care clinics [ Time Frame: 24 Weeks ]
  • To evaluate the efficacy of valacyclovir in reducing HSV-2 viral shedding in HIV/HSV-2 positive subjects [ Time Frame: 24 weeks ]
  • To evaluate the efficacy of valacyclovir in reducing plasma HIV-1 RNA viral load in HIV-HSV-2 positive subjects [ Time Frame: 24 weeks ]
  • To evaluate the safety of valacyclovir for the suppression of genital herpes in HIV/HSV-2 positive subjects. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00803543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: Valacyclovir
    500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
    Other Name: There are no other names
  • Drug: Placebo
    Dosage: Two tablets once a day for 24 weeks
    Other Name: There are no other names
  • Active Comparator: Valacyclovir
    This is the arm taking Valacyclovir
    Intervention: Drug: Valacyclovir
  • Placebo Comparator: Placebo
    This is the arm taking the placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
April 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00803543
F080718009
No
Not Provided
Plan to Share IPD: No
Nicholas Van Wagoner, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
GlaxoSmithKline
Principal Investigator: Nicholas Van Wagoner, MD University of Alabama at Birmingham
University of Alabama at Birmingham
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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