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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:
Information provided by (Responsible Party):
Rupert Kaul, University of Toronto
ClinicalTrials.gov Identifier:
NCT00946556
First received: July 23, 2009
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  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: 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Rupert Kaul, Dr., University of Toronto
ClinicalTrials.gov 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
HIV
genital immunology
 CD4+ T cell
valacyclovir
HIV seronegativity

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

ClinicalTrials.gov processed this record on May 23, 2013