Primary Objective: To evaluate the incidence of post-herpetic neuralgia (PHN) following treatment with 2 dose regimens of Valnivudine™ compared to Valacyclovir
Secondary Objectives: To evaluate the effect on pain associated with acute herpes zoster (AHZ) of 2 dose regimens of Valnivudine™ compared to Valacyclovir; to describe the effect on lesion formation and healing of 2 dose regimens of Valnivudine™ compared to Valacyclovir
Safety: To evaluate the safety profile of 2 dosing regimens of Valnivudine™ as compared to Valacyclovir
Pharmacokinetic: To evaluate the pharmacokinetic (PK) profile of the active metabolite (CF-1743) of Valnivudine™ after 7 days of dosing at 400 mg once-daily (QD) compared with 400 mg twice-daily (BID)
Methodology: A multicenter, randomized, double-blind, parallel-group, active-controlled comparative study of the safety and efficacy of 2 dosing regimens of Valnivudine™ versus Valacyclovir administered for 7 days in subjects with uncomplicated AHZ. Subjects diagnosed with uncomplicated AHZ within 120 hours of lesion appearance and Worst Pain in the Last 24 hours of ≥4 (0-10 numerical rating scale) at Visit 1/Day 1, will be randomized (1:1:1) to one of 3 treatment groups and will begin study treatment at Visit 1/Day 1 to either:
- Valnivudine™ 400 mg QD
Valnivudine™ 400 mg BID (total daily dose of 800 mg)
Valacyclovir 1000 mg 3 times a day for a total daily dose of 3000 mg
Efficacy assessments for lesion status and AHZ pain are captured until Day 120.