Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

March 21, 2012 updated by: Rupert Kaul, University of Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Women's Health in Women's Hands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • HSV2 infected

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of CD4+ T cells on a cervical cytobrush.
Time Frame: Monthly intervals for 5 months
Monthly intervals for 5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (ESTIMATE)

July 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HET-85518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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