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

Sponsor
University Health Network, Toronto
Study ID
NCT00860977
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • valacyclovir — DRUG
    oral valacyclovir 500mg twice daily
  • Placebo — DRUG
    Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Study Details

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.

Key Dates

Start date
Mar 31, 2010
Status verified
Mar 2018
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
  • Experimental: Valacyclovir
    oral valacyclovir 500mg twice daily

Primary Outcome Measure

annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time. [ Time Frame: up to 5 years ]

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