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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genital Herpes; Herpes Genitalis

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

Summary

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

Eligibility

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.

Locations and Contacts

GSK Investigational Site, Buenos Aires 1221, Argentina

GSK Investigational Site, Buenos Aires C1114AAP, Argentina

GSK Investigational Site, Rio de Janeiro 20 551-030, Brazil

GSK Investigational Site, Birmingham, Alabama 35294, United States

GSK Investigational Site, Edmonton, Alberta T6G 2C8, Canada

GSK Investigational Site, Phoenix, Arizona 85016, United States

GSK Investigational Site, Tucson, Arizona 85710, United States

GSK Investigational Site, Anaheim, California 92805, United States

GSK Investigational Site, Beverly Hills, California 90211, United States

GSK Investigational Site, Davis, California 95616, United States

GSK Investigational Site, Fair Oaks, California 95628, United States

GSK Investigational Site, Los Angeles, California 90048, United States

GSK Investigational Site, Sacramento, California 95816, United States

GSK Investigational Site, Sacramento, California 95825, United States

GSK Investigational Site, San Diego, California 92123, United States

GSK Investigational Site, San Diego, California 92128, United States

GSK Investigational Site, San Francisco, California 94102, United States

GSK Investigational Site, Santa Ana, California 92704, United States

GSK Investigational Site, Hartford, Connecticut 06012, United States

GSK Investigational Site, New Britain, Connecticut 06052, United States

GSK Investigational Site, Clearwater, Florida 33759, United States

GSK Investigational Site, Coral Gables, Florida 33134, United States

GSK Investigational Site, Melbourne, Florida 32901, United States

GSK Investigational Site, Palm Springs, Florida 33461, United States

GSK Investigational Site, Venice, Florida 34285, United States

GSK Investigational Site, West Palm Beach, Florida 33407, United States

GSK Investigational Site, Alpharetta, Georgia 30005, United States

GSK Investigational Site, Atlanta, Georgia 30310, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Springfield, Illinois 62702, United States

GSK Investigational Site, Indianapolis, Indiana 46202 - 5124, United States

GSK Investigational Site, South Bend, Indiana 46601, United States

GSK Investigational Site, New Orleans, Louisiana 70114, United States

GSK Investigational Site, Winnipeg, Manitoba R3C 0N2, Canada

GSK Investigational Site, Boston, Massachusetts 02114, United States

GSK Investigational Site, Taunton, Massachusetts 02780, United States

GSK Investigational Site, Portage, Michigan 49024, United States

GSK Investigational Site, Las Vegas, Nevada 89128, United States

GSK Investigational Site, Bronx, New York 10461, United States

GSK Investigational Site, Brooklyn, New York 11203, United States

GSK Investigational Site, Endicott, New York 13760, United States

GSK Investigational Site, Stony Brook, New York 11794-8091, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Tulsa, Oklahoma 74104, United States

GSK Investigational Site, Ottawa, Ontario K1S 0G8, Canada

GSK Investigational Site, Toronto, Ontario M5V 2T3, Canada

GSK Investigational Site, Portland, Oregon 97210, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19103, United States

GSK Investigational Site, Montreal, Quebec H2L 4P9, Canada

GSK Investigational Site, Québec, Quebec G1S 2L6, Canada

GSK Investigational Site, Sainte-Foy, Quebec G1V 4G2, Canada

GSK Investigational Site, Santiago, Región Metro De Santiago 7580206, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago 8380456, Chile

GSK Investigational Site, East Providence, Rhode Island 02914, United States

GSK Investigational Site, Porto Alegre, Rio Grande Do Sul 90035-903, Brazil

GSK Investigational Site, Porto Alegre, Rio Grande Do Sul 90470-340, Brazil

GSK Investigational Site, Memphis, Tennessee 38104, United States

GSK Investigational Site, Memphis, Tennessee 38120, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Georgetown, Texas 78626, United States

GSK Investigational Site, Houston, Texas 77058, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Spokane, Washington 99204, United States

GSK Investigational Site, La Crosse, Wisconsin 54601, United States

GSK Investigational Site, Milwaukee, Wisconsin 53209-0996, United States

GSK Investigational Site, Waukesha, Wisconsin 53186, United States

Additional Information

Starting date: June 2004
Last updated: May 10, 2013

Page last updated: August 23, 2015

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