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OpenTrials
Completed

NCT Number: NCT00860977

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male HIV Infections Herpes Genitalis Herpes Simplex Herpes Simplex Type II Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Male Urogenital Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundación Huesped, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valacyclovir

Drug

oral valacyclovir 500mg twice daily

Other names: Valtrex

Placebo

Drug

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

Primary outcomes

  1. annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.

    Time frame: up to 5 years

Secondary outcomes

  1. 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

  2. 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

  3. Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up

    Time frame: up to 5 years

  4. Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine)

    Time frame: up to 5 years

  5. Frequency of episodes of HSV reactivations at any anatomic site

    Time frame: up to 5 years

  6. 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

  7. Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point

    Time frame: up to 5 years

Other outcomes

  1. analysis of inflammatory markers in HIV disease progression, HIV Resistance Mutations and other herpesvirus serologies

    Time frame: up to 6 years

  2. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • CIHR Canadian HIV Trials Network

Registry information

Official study title

VALacyclovir In Delaying Antiretroviral Treatment Entry

Acronym: VALIDATE

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2009
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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