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

Not Applicable

Completed

• Conditions: Herpes Simplex Type Two Infection; HIV Infections
• Interventions: Drug: Valacyclovir; Drug: Placebo

• Registration Number: NCT00946556
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Study Start: 2010-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Female
• HSV2 infected

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Exclusion Criteria

• HIV infected
• Pregnant
• Taking HSV2 therapy
• Current/recent (past 3 months) genital infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Valacyclovir	Placebo	Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Placebo	Valacyclovir	Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Valacyclovir	Valacyclovir	Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Primary Outcome Measures

Name	Time	Method
Number of CD4+ T cells on a cervical cytobrush.	Monthly intervals for 5 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Women's Health In Women's Hands; 🇨🇦 Toronto, Ontario, Canada