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This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FV-100 400 mg QD | Experimental | FV-100 400mg QD |
|
| FV-100 400mg BID | Experimental | FV-100 400mg BID(total daily dose of 800mg) |
|
| valacyclovir | Active Comparator | valacyclovir 1000mg TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FV-100 | Drug | antiviral nucleoside analog |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir. | efficacy measure | Day 1 to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI) | efficacy measure | Day 1 to Day 120 |
| The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sullivan-Bolyai | CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TX | Webster | Texas | 77598 | United States |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C526677 | FV-100 |
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| valacyclovir | Drug | antiviral nucleoside analog |
|
|
efficacy measure
| Day 1 to Day 120 |
| The number and classification of adverse events in 2 dosing regimens of FV-100 | Safety measure | Day 1 to Day 120 |
| The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID | Pharmacokinetic | Day 1 to Day 120 |
| D007239 | Infections |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |