A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients

Condition(s) targeted: Genital Herpes

Intervention: valaciclovir (Valtrex) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.

Official title: An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6- Month Study of the Efficacy and Safety of Valaciclovir 1g Once Daily Vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Subjects

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

To determine the efficacy of administering valaciclovir 1 gram once daily for 6 months

vs. placebo for genital herpes suppressive therapy in immunocompetent newly diagnosed

subjects, the primary endpoint is time to first genital herpes recurrence

Secondary outcome:

Secondary measures include: adverse events, serious adverse events, etc.

Number of genital herpes recurrences within the study period

Time to first oral HSV outbreak

Collection of HSV-2 culture isolates to assess for resistance to acyclovir.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- In overall general good health.

- Females can enter and participate in this study if they are of non-childbearing

potential (i. e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.

- Must be newly diagnosed with a first recognized episode of GH at the time of the

Screening Visit or within 3 months prior to the Screening Visit.

Exclusion criteria:

- Known or suspected to be immunocompromised (e. g., subjects receiving immunosuppressive

therapy or chemotherapy for malignancy, or are seropositive for HIV).

- Received an investigational drug in the 30 days prior to the study.

- Receiving systemic antiviral or immunomodulatory treatments.

- Must not have received systemic antiviral treatments (e. g., valaciclovir, Famvir

(famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.

- Clinically significant impaired renal function as defined by a creatinine clearance

<30 ml/min, calculated using the Cockcroft-Gault formula.

- Clinically significant impaired hepatic function defined as an ALT (alanine

transaminase) level > 5 times the normal upper limit.

- Subjects with active liver disease.

- Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of

valaciclovir formulations.

- Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or

valganciclovir.

- Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction

that might impair drug pharmacokinetics.

- Women contemplating pregnancy within the duration of the study drug dosing period.

- Women who are pregnant and/or nursing mothers

- Current history of alcohol or drug abuse.

- Received suppressive (daily) therapy for genital herpes prior to enrollment.

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Starting date: June 2004
Last updated: August 10, 2006