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Therapeutics |
Clinical impact ratings GP/FP/Primary care






Infectious diseases 





Key Words: acyclovir antiviral agents herpes genitalis herpesvirus 2 (human)
| The first 150 words of the full text of this article appear below. |
METHODS
Design:
randomised placebo controlled trial.
Allocation:
concealed.*
Blinding:
blinded {participants, healthcare providers, data collectors, data analysts, and outcome assessors}
.*
Follow up period:
8 months.
Setting:
96 sites in the US, Canada, Europe, Latin America, and Australia.
Participants:
1498 couples
18 years who were immunocompetent, heterosexual, monogamous, in good health, and using effective contraception. One (source) partner had clinically symptomatic genital HSV-2 infection, presence of recurrent genital herpes with <10 episodes/year, and non-use of any daily antiviral therapy. The other (susceptible) partner had HSV-2 seronegativity on Western blot analysis.
Intervention:
oral valacyclovir, 500 mg once daily (n = 743), or matching placebo (n = 741) for source partners. Both partners received counselling on safer sex practices and were offered condoms at monthly visits.
Outcomes:
laboratory confirmed clinically symptomatic first episode of genital HSV-2 infection (susceptible partner) and recurrence of genital HSV-2 infection (source partner).
Participant follow up:
99% (1484 couples,
Morten Lindbaek, MD
University of Oslo
Oslo, Norway
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