Valacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial

About the study

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 herpes simplex virus type 1 and 2 (HSV-2, HSV-2) co-infected adults.

Trial participants will be randomly assigned to either a valacyclovir group 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 enrolment or until primary end-point is reached (e.g., the need to start HAART). There will also be an additional rollover year after participants start HAART.

This is a multi-centre, randomized, placebo-controlled trial recruiting 230 participants over two years at 15 sites across Canada, Brazil, and Argentina.

About the disease/condition

Herpes simplex virus is among the most common co-infections in individuals infected with HIV with prevalence rates of 52-95%. HSV-2 is associated with increased HIV-infection, disease progression and transmission. HSV-1 may also adversely impact on HIV.

Study Approach

Valacyclovir is a Health Canada approved, safe and well-tolerated HSV medication with over 10 years of public use. Anti-HSV 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.

CTN 240 researchers hypothesize that valacyclovir in co-infected adults may slow the rate of HIV disease progression and the need to initiate HAART.

Results of this trial could lead to valacyclovir as a therapeutic strategy for delaying the need for initiating lifelong antiretroviral therapy.

Participating Sites

British Columbia, Alberta, Ontario, Quebec, Nova Scotia

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