HSV-2 is a common, sexually transmitted virus seen in up to 50-95% of people living with HIV. HSV-2 may cause recurring, painful ulcers in the genital, oral, and anal areas, and can be treated with antiviral medications such as valacyclovir. Research shows that HSV-2 increases HIV levels in people infected with both viruses, regardless of whether or not it causes ulcers. HSV-1 may also increase HIV levels.

The VALIDATE study was a multi-centre, randomized clinical trial of twice daily oral Valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART. Treatment to control HSV symptoms and shedding may have important health benefits in people infected with both viruses, and two prior studies have shown that the related anti-herpes medication acyclovir can slow HIV disease progression somewhat. However, this possibility has not been adequately studied using the same medication being used in this study, valacyclovir, or in comparable doses.

The VALIDATE Main study closed following the START study results recommending patients start HAART as soon as possible following diagnosis, regardless of CD4 count, in order to minimize long term complications due to HIV.

You can read more about this study here: Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial

This project was supported by a research grant from the Canadian Institutes of Health Research and the Canadian HIV Trials Network.