Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

Sponsor
University of Washington
Study ID
NCT01026454
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • acyclovir — DRUG
    acyclovir 400 mg orally, twice daily for 12 weeks
  • valacyclovir — DRUG
    valacyclovir 1.5 g orally, twice daily, for 12 weeks

Study Details

The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.

Key Dates

Start date
Feb 28, 2010
Status verified
Mar 2014
Primary completion
Nov 30, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: acyclovir
    acyclovir 400 mg orally twice daily
  • Active Comparator: valacyclovir
    valacyclovir 1.5 g orally twice daily

Primary Outcome Measure

Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir. [ Time Frame: Weekly for 12 weeks per intervention ]

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