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Clinical Trials

MainTitle

Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? (VALIDATE)

This study is ongoing, but not recruiting participants.
Sponsor
University Health Network, Toronto

Collaborator
CIHR Canadian HIV Trials Network

Information provided by (Responsible Party)
University Health Network, Toronto
ClinicalTrials.gov Identifier
NCT00860977

First received: March 11, 2009
Last updated: June 2, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infection
Herpes Simplex Type II
HIV Infections

Drug : valacyclovir
Drug : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VALacyclovir In Delaying Antiretroviral Treatment Entry

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures

  • annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time. [ Time Frame: up to 5 years ]
Secondary Outcome Measures:
  • 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. [ Time Frame: up to 5 years ]
  • Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time [ Time Frame: up to 5 years ]
  • Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up [ Time Frame: up to 5 years ]
  • Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine) [ Time Frame: up to 5 years ]
  • Frequency of episodes of HSV reactivations at any anatomic site [ Time Frame: up to 5 years ]
  • Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV [ Time Frame: up to 5 years ]
  • Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point [ Time Frame: up to 5 years ]
Other Outcome Measures:
  • analysis of inflammatory markers in HIV disease progression, HIV Resistance Mutations and other herpesvirus serologies [ Time Frame: up to 6 years ]
  • genetic testing of HLA-B*5701 and HLA-B*5703 status, and future genetic markers related to HIV disease progression and the impact of herpes and valacyclovir [ Time Frame: up to 5 years ]

Enrollment: 202
Study Start Date: March 2010
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo Comparator: Placebo
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
Drug: Placebo

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Experimental: Valacyclovir
oral valacyclovir 500mg twice daily
Drug: valacyclovir

oral valacyclovir 500mg twice daily

Other Name: Valtrex
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860977

Locations

Argentina
Fundación Huesped
Buenos Aires, Argentina, C1202ABB
Brazil
Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro, Brazil
Ambulatorio de Infectologia da UNIFESP
Sao Paulo, Brazil, 04040-002
Centro de Referencia e Treinamento em DST/AIDS
Sao Paulo, Brazil, 04121-000
Canada
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
B.C. Women's Hospital & Health Centre - Oak Tree Clinic
Vancouver, British Columbia, Canada, V6H 1N1
Vancouver Infectious Disease Clinic
Vancouver, British Columbia, Canada, V6Z 2C7
Cool Aid Community Health Centre
VIctoria, British Columbia, Canada, V8W 1M8
CDHA, QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
McMaster University Health Sciences Centre
Hamilton, Ontario, Canada, L8N 3Z5
The Ottawa Hospital, General Campus Divsions of Infectious Diseases
Ottawa, Ontario, Canada, K1H 8L6
University of Ottawa Health Services
Ottawa, Ontario, Canada, K1N 6N5
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M2N 3M5
St. Clair Medical Associates
Toronto, Ontario, Canada, M4K 1N1
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 1E3
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2L 4M1
Centre Hospitalier Universitaire de Quebec-Pavillon CHUL
Quebec, Canada, G1V 4G2
United Kingdom
Brighton & Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 1ES
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
St. Stephen's AIDS Trust
London, United Kingdom, SW10 9NH
St. Mary's Hospital
London, United Kingdom, W2 1NY

Sponsors and Collaborators

University Health Network, Toronto
CIHR Canadian HIV Trials Network

Investigators

Principal Investigator: Sharon L Walmsley, MD FRCPC MSc University Health Network, Toronto
Principal Investigator: Darrell HS Tan, MD FRCPC University Health Network, Toronto
More Information

More Information


Responsible Party: University Health Network, Toronto  
ClinicalTrials.gov Identifier: NCT00860977   History of Changes  
Other Study ID Numbers: CTN 240  
  ISRCTN66756285  
Study First Received: March 11, 2009  
Last Updated: June 2, 2017  

Keywords provided by University Health Network, Toronto:

HIV
Herpes simplex virus type II
Genital herpes
Treatment Naive

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Simplex
Valacyclovir
Acyclovir

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.