Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? (VALIDATE)

This is an interventional treatment trial for HIV Infection focused on measuring HIV, Herpes simplex virus type II, Genital herpes, Treatment Naive Read More

Inclusion Criteria:

• 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 Criteria:

• 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