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Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? | Clinical Trials | Clareo Health

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

VALacyclovir In Delaying Antiretroviral Treatment Entry

NCT00860977•University Health Network, Toronto

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (25)

Fundación Huesped

Buenos Aires, Argentina

Instituto de Pesquisa Clínica Evandro Chagas

Rio de Janeiro, Brazil

Ambulatorio de Infectologia da UNIFESP

São Paulo, Brazil

Centro de Referencia e Treinamento em DST/AIDS

São Paulo, Brazil

University of Alberta

Edmonton, Alberta, Canada

B.C. Women's Hospital & Health Centre - Oak Tree Clinic

Vancouver, British Columbia, Canada

Vancouver Infectious Disease Clinic

Vancouver, British Columbia, Canada

Cool Aid Community Health Centre

Victoria, British Columbia, Canada

CDHA, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

McMaster University Health Sciences Centre

Hamilton, Ontario, Canada

Key Dates

Start Date

March 1, 2010

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2015

Last Updated

March 6, 2018

Enrollment

202

ACTUAL participants

Conditions

HIV InfectionHerpes Simplex Type IIHIV Infections

Interventions

valacyclovir

DRUG

Placebo

DRUG

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RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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