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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946556
First Posted: July 27, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rupert Kaul, University of Toronto
  Purpose
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: Quadruple (Participant, Care Provider, 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 Rupert Kaul, University of Toronto:

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

Secondary Outcome Measures:
  • Number of immature dendritic cells on a cervical cytobrush [ Time Frame: Monthly intervals for 5 months ]
  • Proinflammatory cytokine/chemokine levels in cervicovaginal secretions [ Time Frame: Monthly intervals for 5 months ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • HSV2 infected

Exclusion Criteria:

  • HIV infected
  • Pregnant
  • Taking HSV2 therapy
  • Current/recent (past 3 months) genital infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946556


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rupert Kaul, Dr., University of Toronto
ClinicalTrials.gov Identifier: NCT00946556     History of Changes
Other Study ID Numbers: HET-85518
First Submitted: July 23, 2009
First Posted: July 27, 2009
Last Update Posted: October 12, 2017
Last Verified: March 2012

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

Additional relevant MeSH terms:
HIV Infections
Infection
Communicable Diseases
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents