Clinical Trials

Overview

Title: A Multicenter, Randomized, Double-Blind, Parallel Group, Comparative Study of Valnivudine™ vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster-Associated Pain

Condition: Shingles/Herpes Zoster

Interventions: Valnivudine™; Valacyclovir

Learn about the Valnivudine™ Clinical Trial at GotShingles.com >>

Objectives

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.

Eligibility

Age: 30 years and up

Gender: Both

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
  • Have zoster-related pain
  • Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash

Exclusion Criteria:

  • Have multidermal or disseminated AHZ
  • Have facial, ophthalmologic or oral manifestations
  • Have received Zostavax

Overview

Title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of TXL™ in Healthy Subjects

Condition: Infectious Disease

Interventions: TXL™; Placebo

Objectives

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at increasing dose levels

Secondary Objective: To evaluate the pharmacokinetics of multiple doses of TXL™ at increasing dose levels, in a fasted state; to evaluate the pharmacokinetics of a single dose of TXL™ 50 mg in a fed state

Eligibility

Age: 18 years to 55 years

Gender: Both

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Capable of giving written informed consent
  • Capable of completing study requirements

Exclusion Criteria:

  • Positive result for HIV, HBV, or HCV
  • History or medical condition which could impact patient safety
  • Current or past abuse of alcohol or illicit drugs
  • Participation in another clinical trial within the past 30 days

Overview

Title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TXL™ in HBV-infected Subjects

Condition: Infectious Disease

Interventions: TXL™; TDF (Viread)

Objectives

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at multiple ascending dose levels; to evaluate the antiviral activity of TXL™ versus Tenofovir disproxil fumarate (TDF; Viread)

Secondary Objective: To evaluate the pharmacokinetics (PK) of multiple doses of TXL™ at multiple dose levels in a fasted state

Eligibility

Age: 18 years to 65 years

Gender: Both

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Capable of giving written informed consent
  • Capable of completing study requirements
  • Chronic hepatitis B positive
  • HBV treatment naïve

Exclusion Criteria:

  • Positive result for HCV (hepatitis C virus), HDV (hepatitis D virus) or HIV (human immunodeficiency virus)
  • History or medical condition that could impact patient safety
  • Current or past abuse of alcohol or illicit drugs
  • Abnormal laboratory value or ECG
  • Pregnant or breastfeeding
  • Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis
  • Systemic immunosuppression
  • Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug