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

University Health Network, Toronto

Status and phase

Completed

Phase 3

Conditions

Herpes Simplex Type II

HIV Infection

HIV Infections

Treatments

Drug: Placebo

Drug: valacyclovir

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00860977

ISRCTN66756285

CTN 240

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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