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CTNPT 017: Valacyclovir for Inflammation Attenuation Trial Pilot (VALIANT Pilot)

Trial results

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Can valacylovir attenuate inflammation in ART-treated HIV-infected individuals with herpes simplex virus type 2?

Objective

Chronic systemic inflammation is a common component of HIV infection, even in people successfully and consistently taking antiretroviral therapy. Because inflammation is thought to contribute to some health complications as well as HIV progression, development of strategies to limit inflammation is a significant area of research. Herpes simplex virus type 2 (HSV-2) is a common co-infection in people living with HIV and may contribute to chronic inflammation. The VALIANT pilot trial investigated whether valacyclovir, a treatment used to suppress HSV-2, could help reduce persistent inflammation in people living with HIV and HSV-2.

Study Population

Sixty adults with both HIV-1 and HSV-2 and taking antiretroviral therapy with no use of anti-HSV therapy over the past 6 months.

Study Design

This study used a 1:1:1 randomized, blinded, placebo-controlled design. Study participants were randomized to one of three groups: 1g valacyclovir, 500 mg valacyclovir, or placebo. All participants were asked to take their study dose twice daily, over a twelve-week period with a 6-week follow-up period. Key inflammatory and immune activation markers were measured at baseline, 6 weeks, 12 weeks and 18 weeks, as well as in the event of a flare-up of HSV.

Results

No difference was seen between the 3 treatment groups in any inflammatory or immune markers measured during the study. Adherence to the treatment regimen was good throughout the trial.

Conclusions

Although valacylovir is known to reduce HIV viral load in people living with HIV and HSV, it had no significant impact on systemic immune activation or inflammation in people living with HIV and HSV-2 taking antiretroviral therapy.

Additional Information

Principal Investigators

Drs. Darrell Tan and Sharon Walmsley
University Health Network
Toronto, Ontario

Publications

Yi TJ, Walmsley SL, Szadkowski L, Raboud JM, Rajwans N, Shannon B, Kumar S, Kain KC, Kaul R, Tan DHS. 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):1331-38.

Tan DHS, Szadkowski L, Raboud JM, Yi TJ, Shannon B, Kaul R, Liles WC, Walmsley SL. Effect of intercurrent infections and vaccinations on immune and inflammatory biomarkers among human immunodeficiency virus-infected adults on suppressive antiretroviral therapy. Open Forum Infect Dis. 2015 Apr;2(2):ofv036.

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