Back to resultsExamining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Primary Purpose
Herpes Simplex Type Two Infection, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Valacyclovir
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Simplex Type Two Infection focused on measuring herpes simplex virus type 2, HIV, genital immunology, CD4+ T cell, valacyclovir, HIV seronegativity
Eligibility Criteria
Inclusion Criteria:
- Female
- HSV2 infected
Exclusion Criteria:
- HIV infected
- Pregnant
- Taking HSV2 therapy
- Current/recent (past 3 months) genital infection
Sites / Locations
- Women's Health In Women's Hands
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Valacyclovir
Arm Description
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Outcomes
Primary Outcome Measures
Number of CD4+ T cells on a cervical cytobrush.
Secondary Outcome Measures
Number of immature dendritic cells on a cervical cytobrush
Proinflammatory cytokine/chemokine levels in cervicovaginal secretions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946556
Brief Title
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Official Title
Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Type Two Infection, HIV Infections
Keywords
herpes simplex virus type 2, HIV, genital immunology, CD4+ T cell, valacyclovir, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Arm Title
Valacyclovir
Arm Type
Experimental
Arm Description
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Description
1g po od for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo po od for 2 months
Primary Outcome Measure Information:
Title
Number of CD4+ T cells on a cervical cytobrush.
Time Frame
Monthly intervals for 5 months
Secondary Outcome Measure Information:
Title
Number of immature dendritic cells on a cervical cytobrush
Time Frame
Monthly intervals for 5 months
Title
Proinflammatory cytokine/chemokine levels in cervicovaginal secretions
Time Frame
Monthly intervals for 5 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
HSV2 infected
Exclusion Criteria:
HIV infected
Pregnant
Taking HSV2 therapy
Current/recent (past 3 months) genital infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Kaul, MD/PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health In Women's Hands
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17314521
Citation
Rebbapragada A, Wachihi C, Pettengell C, Sunderji S, Huibner S, Jaoko W, Ball B, Fowke K, Mazzulli T, Plummer FA, Kaul R. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS. 2007 Mar 12;21(5):589-98. doi: 10.1097/QAD.0b013e328012b896.
Results Reference
background
PubMed Identifier
24664172
Citation
Yi TJ, Shannon B, Chieza L, Su D, Saunders M, Tharao W, Huibner S, Remis R, Raboud J, Kaul R. Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. J Infect Dis. 2014 Sep 1;210(5):708-12. doi: 10.1093/infdis/jiu163. Epub 2014 Mar 23.
Results Reference
derived
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Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
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