Clinical trial NCT00306293: VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
Official title: The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed With Genital Herpes Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Labialis
Keywords: Recurrent Genital Herpes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.


Eligibility criteria: Inclusion Criteria:

* Subject is in overall general good health.
* If female, subject must be of:

  1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal or surgically sterile); or
  2. Childbearing potential, but must have a negative pregnancy test at randomization, and must be compliant with one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug); Have a male partner who is confirmed to be sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Use of contraceptive(s) with a documented failure rate of less than 1% per year, including but not limited to: implants of levonorgestrel, use of injectable progestogen, oral contraceptives (either combined or progestogen only), an intrauterine device (IUD) or spermicide plus a mechanical barrier (condom/diaphragm).
* Subjects must be newly diagnosed with a first recognized episode of genital herpes as described in (a) or (b) below (See Appendix 3): a.HSV-2 seropositive at screen, with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization or b.HSV-2 seronegative at screen, AND HSV-2 culture positive or HSV-2 PCR positive with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization.
* Subject must be willing and able to provide written informed consent and comply with the protocol.

Exclusion Criteria:

* Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
* Subject received an investigational drug in the 30 days prior to the randomization visit.
* Subject is receiving systemic antiviral or immunomodulatory treatments.
* Subjects who have received systemic antiherpetic treatments (e.g., valacyclovir, acyclovir, ganciclovir, famciclovir) within 3 days of starting study drug, or immunomodulatory treatments in the 30 days before starting study drug.
* Subject has clinically significantly impaired renal function as defined by creatinine clearance less than 50ml/min (calculated using the Cockcroft-Gault formula).
* Subjects with a history or evidence of decompensated liver disease, or clinically significantly impaired hepatic function defined as an ALT (alanine transaminase) level \>3 times the normal upper limit.
* Subject is known to be hypersensitive to valacyclovir, acyclovir, ganciclovir or famciclovir.
* Subject has malabsorption or vomiting syndrome or other gastrointestinal dysfunction that may impair drug pharmacokinetics.
* Female subject who is contemplating pregnancy within the duration of the study drug dosing period.
* Female subject who is pregnant and/or nursing.
* Subject with current alcohol or drug abuse.
* Subjects who have received suppressive (daily) therapy for genital herpes prior to randomization. Suppressive therapy is defined as daily antiherpetic therapy of at least 4 weeks duration.
* Subjects with a history of ocular HSV (herpes simplex virus) infection.

Primary outcomes:
measure: Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)
timeFrame: Up to 60 days in each treatment period (Up to 148 days)
Secondary outcomes:
measure: Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
timeFrame: Up to 60 days in each treatment period (Up to 148 days)
measure: Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
timeFrame: Up to 60 days in each treatment period (Up to 148 days)
measure: Percentage of Participants With no Shedding
timeFrame: Up to 60 days in each treatment period (Up to 148 days)
measure: Percentage of Participants With at Least One Genital Herpes Recurrence
timeFrame: Up to 60 days in each treatment period (Up to 148 days)
measure: Median Time to First Genital Herpes Recurrence (Days)
timeFrame: Up to Day 68
measure: Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: Up to 148 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Fair Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Boynton Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Portage
country: United States
facility: GSK Investigational Site
state: Michigan
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: