HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Sponsor
University of Washington
Study ID
NCT00465205
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Valacyclovir — DRUG
    500mg oral twice daily
  • Matching Placebo — DRUG
    500 mg oral twice daily

Study Details

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission. The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation. This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Key Dates

Start date
Jan 31, 2005
Status verified
Aug 2013
Primary completion
Dec 31, 2005
Completion
Dec 31, 2007

Study Design

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

Arms

  • Experimental: I

Primary Outcome Measure

Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ]

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