Valaciclovir to Prevent Transmission of Herpes Simplex Virus

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

This is a randomized, multicenter, double-blind, placebo-controlled Phase III study to evaluate the effect of valaciclovir in preventing the transmission of herpes simplex virus (HSV) in heterosexual couples discordant for the presence of herpes simplex type 2 virus (HSV-2) antibody. The seropositive source partner will be randomized to receive valaciclovir 500 mg once daily or placebo for 8 months, and the susceptible seronegative partner will be monitored for clinical and subclinical (serological) acquisition of HSV. Couples must be 18 years of age or older, in general good health, and in...

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA - SOURCE PARTNER
• • 18 years of age or older.
• • General good health as determined by current medical status and laboratory tests.
• • Active heterosexual relationship with susceptible partner.
• • Presence of HSV-2 serum antibody as determined by Western blot analysis.
• • History of symptomatic recurrent genital herpes.
• • Off HSV suppressive therapy upon entering study.
• • In the opinion of the investigator, able to comply with protocol requirements.
• • In the investigator's opinion, subjects must be candidates for receiving suppressive therapy for management of their disease.
• • Written informed consent.
• EXCLUSION CRITERIA - SOURCE PARTNER:
• • Patients who are known or suspected to be immunocompromised (e.g., patients receiving immunosuppressive therapy, patients with malignancy or seropositive for HIV).
• • Subjects with a history of 10 or more HSV recurrences per year.
• • Impaired renal function as defined by serum creatinine greater than 1.5 mg/dL or estimated creatinine clearance less than 30 ml/min.
• • Impaired hepatic function defined as an alanine transaminase (ALT) level greater than 3 times the normal upper limit.
• • Known resistance to aciclovir, famciclovir, or ganciclovir.
• • Known hypersensitivity to aciclovir, valaciclovir, famciclovir, or ganciclovir.
• • Malabsorption syndrome or other gastrointestinal dysfunction that might impair drug dynamics.
• • Subjects known to be lactose intolerant.
• • Women contemplating pregnancy within the duration of study drug dosing for this study.
• • Women of child bearing potential not using an effective method of contraception.
• • Positive pregnancy test (or pregnant females or nursing mothers).
• • INCLUSION CRITERIA - SUSCEPTIBLE PARTNER
• • 18 years of age or older.
• • General good health as determined by current medical status.
• • Active monogamous, heterosexual relationship with source partner.
• • Absence of HSV-2 serum antibody as determined by Western blot analysis.
• • In the investigator's opinion, able to comply with protocol requirements.
• • Written informed consent.
• EXCLUSION CRITERIA - SUSCEPTIBLE PARTNER:
• • Subjects who are known or suspected to be immunocompromised (e.g., patients receiving immunosuppressive therapy, patients with malignancy or seropositive for HIV).
• • Subjects who have received an active HSV vaccine (subjects known to have received placebo in clinical trials are eligible).
• • Presence of symptomatic genital herpes.
• • Subjects having sexual relations with anyone other than the source partner.
• • Women contemplating pregnancy within the time period of the study.
• • Women of childbearing potential not using an effective method of contraception.
• • Positive pregnancy test (or pregnant females or nursing mothers).