Clinical Trials

MainTitle

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
University of Toronto


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

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.

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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 ClinicalTrials.gov identifier: NCT00946556

Locations

Canada
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

More Information


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  

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:
Infection
Communicable Diseases
HIV Infections
Herpes Simplex
Valacyclovir
Acyclovir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.