A Phase 3 interventional study of Valacyclovir and Placebo in Human Immunodeficiency Virus and Herpes Simplex, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Treatment
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.
Highly active antiretroviral therapy (HAART) has dramatically reduced HIV-1 infection (herein referred to as 'HIV') related morbidity and mortality, transforming an invariably fatal disease into a manageable, chronic condition. Yet even HAART-treated HIV infection is characterized by chronic systemic inflammation and immune activation. This systemic inflammatory response is composed of multiple components, and can be quantified by measuring markers of immune activation, inflammatory cytokines, acute phase reactants, endothelial activation markers, and markers of microbial translocation. This inflammation is clinically relevant, as it may contribute directly to HIV disease progression and non-AIDS related morbidity and mortality in HIV-infected patients. Because this inflammation persists even in the context of suppressive HAART, albeit at modestly decreased levels, adjunctive therapeutic strategies to attenuate this persistent inflammatory response are therefore needed. Herpes simplex virus type 2 is a common, clinically important co-infection seen in individuals living with HIV infection, and may contribute to this ongoing inflammation. This pilot trial will investigate whether short-term valacyclovir for HSV-2 suppression can decrease systemic inflammation in HAART-treated, HIV-1, HSV-2 co-infected individuals.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 60 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Valacyclovir 1g po BID
Drug: Valacyclovir
Valacyclovir 500mg po BID
Drug: Valacyclovir
Inert placebo
Drug: Placebo
Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.
Also known as: Apo-Valacycyclovir, Valtrex
Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.
Percentage activated CD8+ T-cells
Percentage of CD8+ T-cells co-expressing CD38 and HLA-DR
Time frame: 12 weeks
Inflammatory markers
IL-6, hsCRP, sICAM-1, LPS
Time frame: 12 weeks
CD4 cell count
CD4 cell count (absolute and percentage)
Time frame: 12 weeks
Virologic blips
Plasma HIV RNA level \>50 copies/mL but \<1000 copies/mL, followed by a repeat plasma HIV RNA level \<50 copies/mL.
Time frame: 12 weeks
Drug-related adverse events
Adverse events (AEs) are defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not it is related to the medication.
Time frame: 18 weeks
HSV reactivations
Clinical reactivations of herpes simplex virus. Simultaneous reactivations at more than one anatomic site will be counted as a single reactivation event.
Time frame: 12 weeks
Acyclovir-resistant HSV
Clinical reactivations of herpes simplex virus that are microbiologically confirmed to be caused by acyclovir-resistant virus.
Time frame: 18 weeks
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
University Health Network, Toronto