Overview

This trial is active, not recruiting.

Conditions hiv infection, herpes simplex type ii, hiv infections
Treatments valacyclovir, placebo
Phase phase 3
Sponsor University Health Network, Toronto
Collaborator CIHR Canadian HIV Trials Network
Start date March 2010
End date September 2016
Trial size 202 participants
Trial identifier NCT00860977, CTN 240, ISRCTN66756285

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
placebo
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
(Experimental)
oral valacyclovir 500mg twice daily
valacyclovir Valtrex
oral valacyclovir 500mg twice daily

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title VALacyclovir In Delaying Antiretroviral Treatment Entry
Principal investigator Sharon L Walmsley, MD FRCPC MSc
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.