Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection; Herpes Simplex Type II; HIV Infections
Intervention: valacyclovir (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Sharon L Walmsley, MD FRCPC MSc, Principal Investigator, Affiliation: University Health Network, Toronto
Darrell HS Tan, MD FRCPC, Principal Investigator, Affiliation: University Health Network, Toronto
Overall contact:
Sharon L Walmsley, MD FRCPC MSc, Phone: 416-340-4800, Ext: 3871, Email: sharon.walmsley@uhn.on.ca
Summary
This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial
of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for
initiating HAART among HIV infected individuals who neither use nor require HAART, and who
have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study
initiation.
Clinical Details
Official title: VALacyclovir In Delaying Antiretroviral Treatment Entry
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.
Secondary outcome: time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first.Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine) Frequency of episodes of HSV reactivations at any anatomic site Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult (aged 18 years or older or as per Local/Provincial Guidelines)
- documented HIV-1 infection (determined by EIA and Western blot, sites' standard
assays are acceptable if approved in advance by the PIs for the study, Dr. Darrell
Tan and/or Dr. Sharon Walmsley)
- no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to
require chronic anti-HSV therapy during the study
- antiretroviral naïve (no more than 14 days of total prior ARV exposure)
- CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive
occasions, with at least one measurement within 30 days of initiating trial (baseline
visit)
- does not meet recommendations for initiating ARV therapy according to current
guidelines
Exclusion Criteria:
- 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 a therapeutic HIV vaccine or immunotherapy trial
- Enrolled in another trial investigating the impact of another intervention on HIV
disease progression
- HIV elite controller (EC), phenotypically defined here as documented duration of HIV
infection of ≥5 years, a persistent CD4 cell count ≥500 cells/mm3, and a persistent
plasma HIV viral load of <1000 copies/mL in the absence of antiretroviral therapy
Locations and Contacts
Sharon L Walmsley, MD FRCPC MSc, Phone: 416-340-4800, Ext: 3871, Email: sharon.walmsley@uhn.on.ca
Fundación Huesped, Buenos Aires C1202ABB, Argentina; Recruiting
Pedro Cahn, MD, Phone: 5411 49817777
Pedro Cahn, MD, Principal Investigator
Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil; Recruiting
Beatriz Grinsztejn, MD PhD, Principal Investigator
Ambulatorio de Infectologia da UNIFESP, Sao Paulo 04040-002, Brazil; Recruiting
Centro de Referencia e Treinamento em DST/AIDS, Sao Paulo 04121-000, Brazil; Recruiting
Centre Hospitalier Universitaire de Quebec-Pavillon CHUL, Quebec G1V 4G2, Canada; Recruiting
Sylvie Trottier, MD, Phone: 418-654-2705
Sylvie Trottier, MD, Principal Investigator
Brighton & Sussex University Hospitals NHS Trust, Brighton BN2 1ES, United Kingdom; Recruiting
Guy's and St. Thomas' NHS Foundation Trust, London SE1 7EH, United Kingdom; Recruiting
St. Mary's Hospital, London W2 1NY, United Kingdom; Recruiting
St. Stephen's AIDS Trust, London SW10 9NH, United Kingdom; Recruiting
University of Alberta, Edmonton, Alberta T6G 2C8, Canada; Completed
B.C. Women's Hospital & Health Centre - Oak Tree Clinic, Vancouver, British Columbia V6H 1N1, Canada; Recruiting
Vancouver Infectious Disease Clinic, Vancouver, British Columbia V6Z 2C7, Canada; Recruiting
Brian Conway, MD, Phone: 604 642 6429
Brian Conway, MD, Principal Investigator
Cool Aid Community Health Centre, VIctoria, British Columbia V8W 1M8, Canada; Recruiting
Chris Fraser, MD, Phone: 250-385-1466
Chris Fraser, MD, Principal Investigator
CDHA, QEII Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada; Completed
McMaster University Health Sciences Centre, Hamilton, Ontario L8N 3Z5, Canada; Recruiting
Fiona Smaill, MD, Phone: 905-521-2100 ext. 76332
Fiona Smaill, MD, Principal Investigator
The Ottawa Hospital, General Campus Divsions of Infectious Diseases, Ottawa, Ontario K1H 8L6, Canada; Recruiting
Bill Cameron, MD, Phone: 613-737-8902
Bill Cameron, MD, Principal Investigator
University of Ottawa Health Services, Ottawa, Ontario K1N 6N5, Canada; Completed
Maple Leaf Medical Clinic, Toronto, Ontario M5B 1L6, Canada; Recruiting
Jason Brunetta, Phone: 416-465-0856
Jason Brunetta, MD, Principal Investigator
St. Clair Medical Associates, Toronto, Ontario M4K 1N1, Canada; Completed
St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Darrell Tan, MD, Phone: 416-864-5568
Darrell Tan, MD, Principal Investigator
Sunnybrook Health Science Centre, Toronto, Ontario M2N 3M5, Canada; Recruiting
Anita Rachlis, MD, Phone: 416-480-4689
Anita Rachlis, MD, Principal Investigator
University Health Network, Toronto, Ontario M5G 2N2, Canada; Recruiting
Sharon L Walmsley, MD FRCPC, Phone: 416-340-4800, Ext: 3871, Email: sharon.walmsley@uhn.on.ca
Darrell HS Tan, MD FRCPC, Phone: 416-340-4800, Ext: 2240
Darrell HS Tan, MD FRCPC, Sub-Investigator
Sharon L Walmsley, MD, Principal Investigator
Windsor Regional Hospital, Windsor, Ontario N8W 1E3, Canada; Completed
Montreal Chest Institute, Montreal, Quebec H2X 2P4, Canada; Recruiting
Marina Klein, MD, Phone: 514-843-2090
Marina Klein, MD, Principal Investigator
Centre Hospitalier de l'Université de Montréal, Montréal, Quebec H2L 4M1, Canada; Completed
Additional Information
CIHR Canadian HIV Trials Network - CTN 240
Related publications: Tan DH, Raboud JM, Kaul R, Grinsztejn B, Cahn P, Walmsley SL. Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial. Trials. 2010 Nov 24;11:113. doi: 10.1186/1745-6215-11-113.
Starting date: March 2010
Last updated: April 23, 2015
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