MedPath

Valaciclovir

Generic Name
Valaciclovir
Brand Names
Valtrex
Drug Type
Small Molecule
Chemical Formula
C13H20N6O4
CAS Number
124832-26-4
Unique Ingredient Identifier
MZ1IW7Q79D
Background

Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline . Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens .

One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation .

Indication

Valacyclovir is a nucleoside analog DNA polymerase inhibitor indicated for :

Adults

• Cold Sores (Herpes Labialis)

• Genital Herpes

• Treatment of genital herpes lesions in immunocompetent patients (initial or recurrent episode)

• Suppression of genital herpes lesions in immunocompetent or HIV-infected patients

• Reduction of viral transmission

• Herpes Zoster

Pediatric Patients

• Cold Sores (Herpes Labialis)

• Chickenpox

Limitations of use

The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

Associated Conditions
Chickenpox, Genital Herpes, Genital herpes, initial episode, Herpes Labialis, Herpes Zoster, Recurrent Genital Herpes (RGH)
Associated Therapies
Suppression of Recurrent Genital Herpes (RGH)

Herpes Simplex Type 1 Suppression in Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C Infection
Interventions
Drug: Placebo
First Posted Date
2012-04-19
Last Posted Date
2016-09-21
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
19
Registration Number
NCT01580995
Locations
🇺🇸

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS, Jackson, Mississippi, United States

Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

Phase 1
Completed
Conditions
Chronic Hepatitis C Infection
Interventions
Drug: Placebo
First Posted Date
2011-10-17
Last Posted Date
2016-11-22
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
31
Registration Number
NCT01453075
Locations
🇺🇸

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS, Jackson, Mississippi, United States

Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Completed
Conditions
Genital Herpes
Interventions
First Posted Date
2011-07-11
Last Posted Date
2017-05-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
462
Registration Number
NCT01390805

Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

Completed
Conditions
Varicella
Interventions
First Posted Date
2011-07-11
Last Posted Date
2017-05-17
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
379
Registration Number
NCT01390857

To Rescue Cognition With Valaciclovir

Phase 2
Completed
Conditions
Schizophrenia
Psychosis
Interventions
First Posted Date
2011-06-02
Last Posted Date
2016-12-01
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
24
Registration Number
NCT01364792
Locations
🇳🇱

University Medical Center Groningen, University of Groningen, Groningen, Netherlands

Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Phase 4
Completed
Conditions
Genital Herpes
Interventions
First Posted Date
2011-05-03
Last Posted Date
2017-03-09
Lead Sponsor
University of Washington
Target Recruit Count
50
Registration Number
NCT01346475
Locations
🇺🇸

University of Washington Virology Research Clinic, Seattle, Washington, United States

Reduction of Postherpetic Neuralgia in Herpes Zoster

Not Applicable
Completed
Conditions
Herpes Zoster
Post-herpetic Neuralgia
First Posted Date
2010-12-01
Last Posted Date
2010-12-01
Lead Sponsor
Center for Clinical Studies, Texas
Target Recruit Count
133
Registration Number
NCT01250561
Locations
🇺🇸

Center for Clinical Studies, Houston, Texas, United States

A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition

Not Applicable
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-10-18
Last Posted Date
2010-10-18
Lead Sponsor
Ranbaxy Laboratories Limited
Target Recruit Count
36
Registration Number
NCT01222910
Locations
🇮🇳

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited, Noida, Uttar Pradesh, India

A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition

Not Applicable
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-10-18
Last Posted Date
2010-10-18
Lead Sponsor
Ranbaxy Laboratories Limited
Target Recruit Count
40
Registration Number
NCT01222897
Locations
🇮🇳

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited, Noida, Uttar Pradesh, India

Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

Phase 3
Completed
Conditions
Human Immunodeficiency Virus
Herpes Simplex
Interventions
Drug: Placebo
First Posted Date
2010-08-06
Last Posted Date
2016-05-12
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
60
Registration Number
NCT01176409
Locations
🇨🇦

Toronto General Hospital, University Health Network, Toronto, Ontario, Canada

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