Trial record 12 of 30 for:
" August 04, 2010":" September 03, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2? (VALIANT Pilot)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Health Network, Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
Collaborators:
University of Toronto
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01176409
First received: August 4, 2010
Last updated: December 22, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Herpes Simplex |
Drug: Valacyclovir Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | VALacyclovir for Inflammation AttenuatioN Trial Pilot (VALIANT Pilot) |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Percentage activated CD8+ T-cells [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Percentage of CD8+ T-cells co-expressing CD38 and HLA-DR
Secondary Outcome Measures:
- Inflammatory markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]IL-6, hsCRP, sICAM-1, LPS
- CD4 cell count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]CD4 cell count (absolute and percentage)
- Virologic blips [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Plasma HIV RNA level >50 copies/mL but <1000 copies/mL, followed by a repeat plasma HIV RNA level <50 copies/mL.
- Drug-related adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]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.
- HSV reactivations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Clinical reactivations of herpes simplex virus. Simultaneous reactivations at more than one anatomic site will be counted as a single reactivation event.
- Acyclovir-resistant HSV [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Clinical reactivations of herpes simplex virus that are microbiologically confirmed to be caused by acyclovir-resistant virus.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High dose valacyclovir
Valacyclovir 1g po BID
|
Drug: Valacyclovir
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.
Other Names:
|
|
Active Comparator: Low dose valacyclovir
Valacyclovir 500mg po BID
|
Drug: Valacyclovir
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.
Other Names:
|
|
Placebo Comparator: Placebo
Inert placebo
|
Drug: Placebo
Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176409
Contacts
| Contact: Darrell H.S. Tan, MD FRCPC | 416-340-5077 | darrell.tan@gmail.com |
| Contact: Sharon L Walmsley, MD FRCPC MSc | 416-340-3871 |
Locations
| Canada, Ontario | |
| Toronto General Hospital, University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Contact: Warmond Chan 416-340-4800 ext 6954 warmond.chan@uhn.on.ca | |
| Sub-Investigator: Darrell H.S. Tan, MD FRCPC MSc | |
| Principal Investigator: Sharon L Walmsley, MD FRCPC MSc | |
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Darrell H.S. Tan, MD FRCPC | University Health Network, University of Toronto |
| Principal Investigator: | Sharon L Walmsley, MD FRCPC MSc | University Health Network, University of Toronto |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sharon Walmsley, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01176409 History of Changes |
| Other Study ID Numbers: | VALIANT-001 |
| Study First Received: | August 4, 2010 |
| Last Updated: | December 22, 2010 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Inflammation Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Pathologic Processes Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013