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NCT Number: NCT00946556

Examining the Ability of Herpes Simplex Virus Type 2 (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.

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Key information

Conditions

Herpes Simplex Type Two Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Health In Women's Hands

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • HSV2 infected

Exclusion criteria

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

Treatment and study plan

Valacyclovir

Drug

1g po od for 2 months

Placebo

Drug

Placebo po od for 2 months

Primary outcomes

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

    Time frame: Monthly intervals for 5 months

Secondary outcomes

  1. Number of immature dendritic cells on a cervical cytobrush

    Time frame: Monthly intervals for 5 months

  2. Proinflammatory cytokine/chemokine levels in cervicovaginal secretions

    Time frame: Monthly intervals for 5 months

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2009
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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