HIV Infection | Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?
HIV Infection research study
What is the primary objective of this study?
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 among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Herpes Simplex Type II
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:valacycloviroral valacyclovir 500mg twice daily
Drug:PlaceboOdourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboOdourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
Valacycloviroral valacyclovir 500mg twice daily
Start Date: March 2010
Completed Date: August 2015
Phase: Phase 3
Primary Outcome: annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.
Secondary Outcome: time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first.
Study sponsors, principal investigator, and references
Principal Investigator: Sharon L Walmsley, MD FRCPC MSc
Lead Sponsor: University Health Network, Toronto
Collaborator: CIHR Canadian HIV Trials Network
Tan DH, Raboud JM, Kaul R, Grinsztejn B, Cahn P, Walmsley SL. Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial. Trials. 2010 Nov 24;11:113. doi: 10.1186/1745-6215-11-113.