Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

Phase 3 Completed 60 enrolled University Health Network, Toronto Canadian Institutes of Health Research (CIHR) · collab University of Toronto · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the levels of immune and inflammatory markers among HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to \<50 copies/mL, between those randomized to valacyclovir and placebo, over a twelve-week intervention period.

Timeline

Start: 2010-09
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

paper Valacyclovir was not associated with significant changes in any primary or secondary immunological outcomes in bivariate or multivariable models. PMID 23946220 ↗

paper Valacyclovir did not decrease systemic immune activation or inflammatory biomarkers in HIV-1/HSV-2-coinfected adults on suppressive ART. PMID 23946220 ↗

Publications

Results Yi TJ, Walmsley S, Szadkowski L, Raboud J, Rajwans N, Shannon B, Kumar S, Kain KC, Kaul R, Tan DH. A randomized controlled pilot trial of valacyclovir for attenuating inflammation and immune activation in HIV/herpes simplex virus 2-coinfected adults on suppressive antiretroviral therapy. Clin Infect Dis. 2013 Nov;57(9):1331-8. doi: 10.1093/cid/cit539. Epub 2013 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valacyclovir	Unknown	500 mg	Oral
Subject	Valacyclovir	Unknown	1 g	Oral