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)

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

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
Drug: Valacyclovir
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

Valacyclovir 1000 mg Tablet Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-06-23
Last Posted Date
2010-06-23
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
60
Registration Number
NCT01149499
Locations
🇺🇸

PRACS Institute, Ltd., East Grand Forks, Minnesota, United States

Valacyclovir 1000 mg Tablet Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-06-23
Last Posted Date
2024-08-21
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
36
Registration Number
NCT01149460
Locations
🇨🇦

Anapharm Inc., Sainte-Foy, Quebec, Canada

An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

Not Applicable
Withdrawn
Conditions
HIV
HIV Infections
First Posted Date
2010-01-29
Last Posted Date
2012-12-05
Lead Sponsor
University of Washington
Registration Number
NCT01059084

Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Phase 1
Conditions
Infection
Hepatitis C Virus Infection
Herpesvirus 2, Human
First Posted Date
2009-12-23
Last Posted Date
2011-11-06
Lead Sponsor
G.V. (Sonny) Montgomery VA Medical Center
Target Recruit Count
50
Registration Number
NCT01037621
Locations
🇺🇸

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

In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

Phase 4
Terminated
Conditions
Viral Disease
Cytomegalovirus Infection
Interventions
First Posted Date
2009-12-23
Last Posted Date
2012-10-15
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
6
Registration Number
NCT01037712
Locations
🇫🇷

Hospital Necker Enfants Malades, Paris, France

Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

Phase 4
Completed
Conditions
HSV Infection
HIV Infection
Interventions
First Posted Date
2009-12-04
Last Posted Date
2014-04-08
Lead Sponsor
University of Washington
Target Recruit Count
32
Registration Number
NCT01026454
Locations
🇰🇪

Thika Partners in Prevention, Thika, Kenya

Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

Not Applicable
Completed
Conditions
Herpes Simplex Type Two Infection
HIV Infections
Interventions
Drug: Valacyclovir
Drug: Placebo
First Posted Date
2009-07-27
Last Posted Date
2012-03-22
Lead Sponsor
University of Toronto
Target Recruit Count
30
Registration Number
NCT00946556
Locations
🇨🇦

Women's Health In Women's Hands, Toronto, Ontario, Canada

© Copyright 2025. All Rights Reserved by MedPath