Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

Sponsor
University Health Network, Toronto
Study ID
NCT01176409
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Valacyclovir — DRUG
    Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.
  • Placebo — DRUG
    Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.

Study Details

The purpose of this study is to compare the levels of immune and inflammatory markers among HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to \<50 copies/mL, between those randomized to valacyclovir and placebo, over a twelve-week intervention period.

Key Dates

Start date
Sep 30, 2010
Status verified
May 2016
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

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

Arms

  • Experimental: High dose valacyclovir
    Valacyclovir 1g po BID
  • Active Comparator: Low dose valacyclovir
    Valacyclovir 500mg po BID
  • Placebo Comparator: Placebo
    Inert placebo

Primary Outcome Measure

Percentage activated CD8+ T-cells [ Time Frame: 12 weeks ]

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