Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00527618
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • valacyclovir — DRUG
    valacyclovir 1000 mg orally twice daily for 12 weeks.
  • acyclovir — DRUG
    acyclovir 400 mg orally twice daily for 12 weeks.

Study Details

To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.

Key Dates

Start date
Dec 31, 2007
Status verified
May 2018
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

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

Arms

  • Active Comparator: Standard-dose acyclovir
    acyclovir 400 mg orally twice daily for 12 weeks.
  • Experimental: High-dose valacyclovir
    valacyclovir 1000 mg orally twice daily for 12 weeks.

Primary Outcome Measure

The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir. [ Time Frame: 26 weeks (12 weeks per drug intervention) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Virology Research ClinicSeattleWashington98122-

Find similar trials in Seattle, WA

By condition
HIV
By specialty
Infectious disease
By research site
University of Washington Virology Research Clinic· Seattle, WA

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