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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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