A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00161434
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • valacyclovir — DRUG
    1 gram daily for 8 weeks
  • placebo — DRUG
    matching placebo for 8 weeks

Study Details

The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.

Key Dates

Start date
Mar 31, 2003
Status verified
Dec 2007
Primary completion
Jun 30, 2006
Completion
Jun 30, 2006

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virology Research ClinicSeattleWashington98122-

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