Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

Sponsor
University of Toronto
Study ID
NCT00946556
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Valacyclovir — DRUG
    1g po od for 2 months
  • Placebo — DRUG
    Placebo po od for 2 months

Study Details

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.

Key Dates

Start date
Apr 30, 2010
Status verified
Mar 2012
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
  • Experimental: Valacyclovir
    Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Primary Outcome Measure

Number of CD4+ T cells on a cervical cytobrush. [ Time Frame: Monthly intervals for 5 months ]

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