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

Human Immunodeficiency Virus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - adult (aged 18 years or older) - documented HIV-1 infection (determined by EIA and Western blot) - documented HSV-2 seropositivity (determined by ELISA during screening) - no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study - sustained plasma HIV RNA<50 copies/mL on HAART for at least 12 months - no active opportunistic infection for at least 12 months Exclusion Criteria: - hepatitis C co-infection - hepatitis B co-infection - pregnancy or actively planning to become pregnant - receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.) - Estimated creatinine clearance <30 mL/min - Other medical condition likely to cause death within 24 months - Enrolled in any other interventional clinical trial

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Human Immunodeficiency Virus

Herpes Simplex

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ValacyclovirValacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.

Drug:PlaceboPlacebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

High dose valacyclovirValacyclovir 1g po BID

Low dose valacyclovirValacyclovir 500mg po BID

PlaceboInert placebo

Study Status

Completed

Start Date: September 2010

Completed Date: August 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Percentage activated CD8+ T-cells

Secondary Outcome: Inflammatory markers

Study sponsors, principal investigator, and references

Principal Investigator: Darrell HS Tan, MD FRCPC

Lead Sponsor: University Health Network, Toronto

Collaborator: University of Toronto

More information:https://clinicaltrials.gov/show/NCT01176409

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.

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