NCT00946556

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

July 23, 2009

Last Update Submit

March 21, 2012

Conditions

Herpes Simplex Type Two InfectionHIV Infections

Keywords

herpes simplex virus type 2HIVgenital immunologyCD4+ T cellvalacyclovirHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Number of CD4+ T cells on a cervical cytobrush.

    Monthly intervals for 5 months

Secondary Outcomes (2)

  • Number of immature dendritic cells on a cervical cytobrush

    Monthly intervals for 5 months

  • Proinflammatory cytokine/chemokine levels in cervicovaginal secretions

    Monthly intervals for 5 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Drug: ValacyclovirDrug: Placebo

Valacyclovir

EXPERIMENTAL

Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Drug: ValacyclovirDrug: Placebo

Interventions

ValacyclovirDRUG

1g po od for 2 months

PlaceboValacyclovir
PlaceboDRUG

Placebo po od for 2 months

PlaceboValacyclovir

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • HSV2 infected

You may not qualify if:

  • HIV infected
  • Pregnant
  • Taking HSV2 therapy
  • Current/recent (past 3 months) genital infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health In Women's Hands

Toronto, Ontario, Canada

Location

Related Publications (2)

  • Rebbapragada A, Wachihi C, Pettengell C, Sunderji S, Huibner S, Jaoko W, Ball B, Fowke K, Mazzulli T, Plummer FA, Kaul R. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS. 2007 Mar 12;21(5):589-98. doi: 10.1097/QAD.0b013e328012b896.

    PMID: 17314521BACKGROUND

  • Yi TJ, Shannon B, Chieza L, Su D, Saunders M, Tharao W, Huibner S, Remis R, Raboud J, Kaul R. Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. J Infect Dis. 2014 Sep 1;210(5):708-12. doi: 10.1093/infdis/jiu163. Epub 2014 Mar 23.

    PMID: 24664172DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rupert Kaul, MD/PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

April 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

CA(1)