Status:
COMPLETED
Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
University of Toronto
Canadian Institutes of Health Research (CIHR)
Conditions:
Human Immunodeficiency Virus
Herpes Simplex
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 random...
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 man...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01176409
Start Date
September 1 2010
End Date
August 1 2013
Last Update
May 12 2016
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2N2