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

This study has been completed.
Information provided by (Responsible Party):
Rupert Kaul, University of Toronto Identifier:
First received: July 23, 2009
Last updated: March 21, 2012
Last verified: March 2012

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.

Condition Intervention
Herpes Simplex Type Two Infection
HIV Infections
Drug: Valacyclovir
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.

Resource links provided by NLM:

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Number of CD4+ T cells on a cervical cytobrush. [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of immature dendritic cells on a cervical cytobrush [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]
  • Proinflammatory cytokine/chemokine levels in cervicovaginal secretions [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Drug: Valacyclovir
1g po od for 2 months
Drug: Placebo
Placebo po od for 2 months
Experimental: Valacyclovir
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
Drug: Valacyclovir
1g po od for 2 months
Drug: Placebo
Placebo po od for 2 months


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female
  • HSV2 infected

Exclusion Criteria:

  • HIV infected
  • Pregnant
  • Taking HSV2 therapy
  • Current/recent (past 3 months) genital infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00946556

Canada, Ontario
Women's Health In Women's Hands
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Toronto
Principal Investigator: Rupert Kaul, MD/PhD University of Toronto
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rupert Kaul, Dr., University of Toronto Identifier: NCT00946556     History of Changes
Other Study ID Numbers: HET-85518
Study First Received: July 23, 2009
Last Updated: March 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
herpes simplex virus type 2
genital immunology
CD4+ T cell
HIV seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Herpes Simplex
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 26, 2015