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

Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Herpes Simplex

Intervention: Valacyclovir (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Darrell H.S. Tan, MD FRCPC, Principal Investigator, Affiliation: University Health Network, University of Toronto
Sharon L Walmsley, MD FRCPC MSc, Principal Investigator, Affiliation: University Health Network, University of Toronto

Overall contact:
Darrell H.S. Tan, MD FRCPC, Phone: 416-340-5077, Email: darrell.tan@gmail.com

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.

Clinical Details

Official title: VALacyclovir for Inflammation AttenuatioN Trial Pilot (VALIANT Pilot)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage activated CD8+ T-cells

Secondary outcome:

Inflammatory markers

CD4 cell count

Virologic blips

Drug-related adverse events

HSV reactivations

Acyclovir-resistant HSV

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Darrell H.S. Tan, MD FRCPC, Phone: 416-340-5077, Email: darrell.tan@gmail.com

Toronto General Hospital, University Health Network, Toronto, Ontario M5G 2N2, Canada; Recruiting
Warmond Chan, Phone: 416-340-4800, Ext: 6954, Email: warmond.chan@uhn.on.ca
Darrell H.S. Tan, MD FRCPC MSc, Sub-Investigator
Sharon L Walmsley, MD FRCPC MSc, Principal Investigator
Additional Information

University Health Network Immunodeficiency Clinic Website

Starting date: September 2010
Last updated: December 22, 2010

Page last updated: August 23, 2015

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