Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

Last updated: May 10, 2016
Sponsor: University Health Network, Toronto
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Inflammation

Aids And Aids Related Infections

Treatment

N/A

Clinical Study ID

NCT01176409
VALIANT-001
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to compare the levels of immune and inflammatory markers among HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL, between those randomized to valacyclovir and placebo, over a twelve-week intervention period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult (aged 18 years or older)

  • documented HIV-1 infection (determined by EIA and Western blot)

  • documented HSV-2 seropositivity (determined by ELISA during screening)

  • no use of chronic anti-HSV therapy for the past 6 months, and not anticipated torequire chronic anti-HSV therapy during the study

  • sustained plasma HIV RNA<50 copies/mL on HAART for at least 12 months

  • no active opportunistic infection for at least 12 months

Exclusion

Exclusion Criteria:

  • hepatitis C co-infection

  • hepatitis B co-infection

  • pregnancy or actively planning to become pregnant

  • receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)

  • Estimated creatinine clearance <30 mL/min

  • Other medical condition likely to cause death within 24 months

  • Enrolled in any other interventional clinical trial

Study Design

Total Participants: 60
Study Start date:
September 01, 2010
Estimated Completion Date:
August 31, 2013

Study Description

Highly active antiretroviral therapy (HAART) has dramatically reduced HIV-1 infection (herein referred to as 'HIV') related morbidity and mortality, transforming an invariably fatal disease into a manageable, chronic condition. Yet even HAART-treated HIV infection is characterized by chronic systemic inflammation and immune activation. This systemic inflammatory response is composed of multiple components, and can be quantified by measuring markers of immune activation, inflammatory cytokines, acute phase reactants, endothelial activation markers, and markers of microbial translocation. This inflammation is clinically relevant, as it may contribute directly to HIV disease progression and non-AIDS related morbidity and mortality in HIV-infected patients. Because this inflammation persists even in the context of suppressive HAART, albeit at modestly decreased levels, adjunctive therapeutic strategies to attenuate this persistent inflammatory response are therefore needed. Herpes simplex virus type 2 is a common, clinically important co-infection seen in individuals living with HIV infection, and may contribute to this ongoing inflammation. This pilot trial will investigate whether short-term valacyclovir for HSV-2 suppression can decrease systemic inflammation in HAART-treated, HIV-1, HSV-2 co-infected individuals.

Connect with a study center

  • Toronto General Hospital, University Health Network

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

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