Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)
Research type
Research Study
Full title
Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)
IRAS ID
88548
Contact name
Simon Barton
Sponsor organisation
University Health Network, Toronto General Hospital
Eudract number
2011-002268-26
ISRCTN Number
ISRCTN66756285
Clinicaltrials.gov Identifier
Research summary
Can Valacyclovir Delay the Need for Initiation of HIV Treatment in HIV-Infected Individuals with Herpes Simplex Virus Type 2?Valacyclovir is an approved, safe and well-tolerated herpes simplex virus type 2 (HSV-2) medication with over 10 years of public use. Anti-HSV-2 medications, such as valacyclovir, are associated with decreased HIV viral loads yet the use of this treatment to slow the rate of CD4 count decline in HIV co-infected adults has not been adequately studied. This study will aim to answer if oral valacyclovir 500mg twice daily can slow the rate of CD4 count decline and ultimately delay the need to start highly active antiretroviral therapy (HAART) in adults with HIV and infrequent recurrences of herpes, who are not currently needing nor taking HAART. Knowledge gained from this study could lead to the introduction of chronic suppressive valacyclovir as a therapeutic strategy used to delay the start of HAART in HIV and HSV-2 co-infected adults. Trial participants will be randomly assigned to either a valacyclovir or a placebo group. Both groups will receive one pill twice a day. Follow-up for all participants will include standard-of-care medical assessments and blood tests for up to five years following study enrollment or until primary end-point is reached (i.e., reaching a CD4 count of = 350 cells/mm3 or starting HAART for any reason). There will also be a rollover period after the endpoint is reached that will add 12 months to the total duration of the study, during which blood inflammatory markers will be followed. This is a multi-centre, randomized, placebo-controlled trial recruiting 480 participants over two years at 25 HIV Clinic sites across Canada, Brazil, Argentina and the United Kingdom.
REC name
London - Riverside Research Ethics Committee
REC reference
12/LO/1698
Date of REC Opinion
19 Nov 2012
REC opinion
Favourable Opinion