Status:
COMPLETED
Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
CIHR Canadian HIV Trials Network
Conditions:
HIV Infection
Herpes Simplex Type II
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART...
Eligibility Criteria
Inclusion
- adult (aged 18 years or older or as per Local/Provincial Guidelines)
- documented HIV-1 infection (determined by EIA and Western blot, sites' standard assays are acceptable if approved in advance by the PIs for the study, Dr. Darrell Tan and/or Dr. Sharon Walmsley)
- no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
- antiretroviral naïve (no more than 14 days of total prior ARV exposure)
- CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 30 days of initiating trial (baseline visit)
- does not meet recommendations for initiating ARV therapy according to current guidelines
Exclusion
- 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 a therapeutic HIV vaccine or immunotherapy trial
- Enrolled in another trial investigating the impact of another intervention on HIV disease progression
- HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of ≥5 years, a persistent CD4 cell count ≥500 cells/mm3, and a persistent plasma HIV viral load of \<1000 copies/mL in the absence of antiretroviral therapy
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00860977
Start Date
March 1 2010
End Date
August 1 2015
Last Update
March 6 2018
Active Locations (25)
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1
Fundación Huesped
Buenos Aires, Argentina, C1202ABB
2
Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro, Brazil
3
Ambulatorio de Infectologia da UNIFESP
São Paulo, Brazil, 04040-002
4
Centro de Referencia e Treinamento em DST/AIDS
São Paulo, Brazil, 04121-000