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

July 23, 2009
March 21, 2012
April 2010
May 2011   (final data collection date for primary outcome measure)
Number of CD4+ T cells on a cervical cytobrush. [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946556 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Herpes Simplex Type Two Infection
  • HIV Infections
  • Drug: Valacyclovir
    1g po od for 2 months
  • Drug: Placebo
    Placebo po od for 2 months
  • Placebo Comparator: Placebo
    Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
    Interventions:
    • Drug: Valacyclovir
    • Drug: Placebo
  • Experimental: Valacyclovir
    Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
    Interventions:
    • Drug: Valacyclovir
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • HSV2 infected

Exclusion Criteria:

  • HIV infected
  • Pregnant
  • Taking HSV2 therapy
  • Current/recent (past 3 months) genital infection
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00946556
HET-85518
No
Rupert Kaul, University of Toronto
University of Toronto
Not Provided
Principal Investigator: Rupert Kaul, MD/PhD University of Toronto
University of Toronto
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP