Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
G.V. (Sonny) Montgomery VA Medical Center
Study ID
NCT01037621
Phase
PHASE1
Status
Unknown

Conditions

  • Hepatitis C Virus Infection
  • Herpesvirus 2, Human
  • Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Valacyclovir — DRUG
    Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Study Details

This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.

Key Dates

Start date
Apr 30, 2010
Status verified
Nov 2011
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Primary Outcome Measure

The number of study participants who experience adverse events while receiving valacyclovir. [ Time Frame: 18 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
G.V. Sonny Montgomery VA Medical CenterJacksonMississippi39216-

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G.V. Sonny Montgomery VA Medical Center· Jackson, MS

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