A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons

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.

This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.

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.