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Trial record 60 of 126 for:    HSV-2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176409
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : May 12, 2016
University of Toronto
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Herpes Simplex Drug: Valacyclovir Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VALacyclovir for Inflammation AttenuatioN Trial Pilot (VALIANT Pilot)
Study Start Date : September 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High dose valacyclovir
Valacyclovir 1g po BID
Drug: Valacyclovir
Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.
Other Names:
  • Apo-Valacycyclovir
  • Valtrex

Active Comparator: Low dose valacyclovir
Valacyclovir 500mg po BID
Drug: Valacyclovir
Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.
Other Names:
  • Apo-Valacycyclovir
  • Valtrex

Placebo Comparator: Placebo
Inert placebo
Drug: Placebo
Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.

Primary Outcome Measures :
  1. Percentage activated CD8+ T-cells [ Time Frame: 12 weeks ]
    Percentage of CD8+ T-cells co-expressing CD38 and HLA-DR

Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 12 weeks ]
    IL-6, hsCRP, sICAM-1, LPS

  2. CD4 cell count [ Time Frame: 12 weeks ]
    CD4 cell count (absolute and percentage)

  3. Virologic blips [ Time Frame: 12 weeks ]
    Plasma HIV RNA level >50 copies/mL but <1000 copies/mL, followed by a repeat plasma HIV RNA level <50 copies/mL.

  4. Drug-related adverse events [ Time Frame: 18 weeks ]
    Adverse events (AEs) are defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not it is related to the medication.

  5. HSV reactivations [ Time Frame: 12 weeks ]
    Clinical reactivations of herpes simplex virus. Simultaneous reactivations at more than one anatomic site will be counted as a single reactivation event.

  6. Acyclovir-resistant HSV [ Time Frame: 18 weeks ]
    Clinical reactivations of herpes simplex virus that are microbiologically confirmed to be caused by acyclovir-resistant virus.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 to require 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176409

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Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Darrell HS Tan, MD FRCPC University Health Network, University of Toronto
Principal Investigator: Sharon L Walmsley, MD FRCPC MSc University Health Network, University of Toronto

Additional Information:
Publications of Results:
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Responsible Party: University Health Network, Toronto Identifier: NCT01176409     History of Changes
Other Study ID Numbers: VALIANT-001
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Herpes Simplex
Pathologic Processes
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents