Herpes Simplex Type Two Infection, HIV Infections
Conditions
Keywords
herpes simplex virus type 2, HIV, genital immunology, CD4+ T cell, valacyclovir, HIV seronegativity
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.
Interventions
DRUGValacyclovir
1g po od for 2 months
DRUGPlacebo
Placebo po od for 2 months
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female * HSV2 infected
Exclusion criteria
* HIV infected * Pregnant * Taking HSV2 therapy * Current/recent (past 3 months) genital infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of CD4+ T cells on a cervical cytobrush. | Monthly intervals for 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of immature dendritic cells on a cervical cytobrush | Monthly intervals for 5 months |
| Proinflammatory cytokine/chemokine levels in cervicovaginal secretions | Monthly intervals for 5 months |
Countries
Canada
Outcome results
None listed