An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3.

Date de début de l'étude : 12 mars 2004

Inclusion Criteria: * CD4+ lymphocyte count \<100cells/mm3 at the screening visit. * Documented history of HIV infections * Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study. * Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test). * 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently. * 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes. Exclusion Criteria: * Kidney diseases. * Liver diseases. * Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir). * Vomiting syndrome. * Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation. * Active AIDS-indicator conditions, as defined by CDC Category C. * Other protocol inclusion and exclusion criteria to be evaluated by the research physician.