HIV Infections Clinical Trial
— VALIANT PilotOfficial title:
VALacyclovir for Inflammation AttenuatioN Trial Pilot (VALIANT Pilot)
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR), University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage activated CD8+ T-cells | Percentage of CD8+ T-cells co-expressing CD38 and HLA-DR | 12 weeks | No |
Secondary | Inflammatory markers | IL-6, hsCRP, sICAM-1, LPS | 12 weeks | No |
Secondary | CD4 cell count | CD4 cell count (absolute and percentage) | 12 weeks | No |
Secondary | Virologic blips | Plasma HIV RNA level >50 copies/mL but <1000 copies/mL, followed by a repeat plasma HIV RNA level <50 copies/mL. | 12 weeks | No |
Secondary | 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. | 18 weeks | Yes |
Secondary | HSV reactivations | Clinical reactivations of herpes simplex virus. Simultaneous reactivations at more than one anatomic site will be counted as a single reactivation event. | 12 weeks | No |
Secondary | Acyclovir-resistant HSV | Clinical reactivations of herpes simplex virus that are microbiologically confirmed to be caused by acyclovir-resistant virus. | 18 weeks | No |
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