MedPath

Acyclovir

Generic Name
Acyclovir
Brand Names
Sitavig, Xerese, Zovirax
Drug Type
Small Molecule
Chemical Formula
C8H11N5O3
CAS Number
59277-89-3
Unique Ingredient Identifier
X4HES1O11F
Background

Acyclovir is a nucleotide analog antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis. Acyclovir is generally used first line in the treatment of these viruses and some products are indicated for patients as young as 6 years old.

Acyclovir was granted FDA approval on 29 March 1982.

Indication

An acyclovir topical cream is indicated to treat recurrent herpes labialis in immunocompetent patients 12 years and older. Acyclovir oral tablets, capsules, and suspensions are indicated to treat herpes zoster, genital herpes, and chickenpox. An acyclovir topical ointment is indicated to treat initial genital herpes and limited non-life-threatening mucocutaneous herpes simplex in immunocompromised patients. An acyclovir cream with hydrocortisone is indicated to treat recurrent herpes labialis, and shortening lesion healing time in patients 6 years and older. An acyclovir buccal tablet is indicated for the treatment of recurrent herpes labialis. An acyclovir ophthalmic ointment is indicated to treat acute herpetic keratitis.

Associated Conditions
Bell's Palsy, Chickenpox, Cytomegalovirus (CMV) Infections, Herpes Simplex Infections, Herpes Zoster, Herpes simplex encephalitis, Herpes simplex of the oral-labial, Herpes simplex type I reactivation, Recurrent Genital Herpes (RGH), Recurrent Herpes Labialis, VZV re-activation, Acute Genital herpes, Acute Herpes labialis, Acute Herpetic keratitis, Severe Genital herpes

Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Phase 2
Conditions
Meniere's Disease
Interventions
Drug: Placebo
First Posted Date
2012-11-20
Last Posted Date
2012-11-20
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
80
Registration Number
NCT01729767
Locations
🇮🇷

Amiralam Hospital, Tehran, Iran, Islamic Republic of

Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

Phase 3
Completed
Conditions
Herpes Zoster
Interventions
First Posted Date
2011-04-01
Last Posted Date
2019-04-17
Lead Sponsor
EMS
Target Recruit Count
177
Registration Number
NCT01327144
Locations
🇧🇷

Allergisa, Campinas, São Paulo, Brazil

🇧🇷

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho, Porto Alegre, RS, Brazil

🇧🇷

Loema, Campinas, SP, Brazil

and more 2 locations

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Phase 3
Completed
Conditions
GENITAL HERPES
Interventions
First Posted Date
2011-01-21
Last Posted Date
2021-04-21
Lead Sponsor
EMS
Target Recruit Count
150
Registration Number
NCT01281007
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

🇧🇷

Caep Centro Avancado de Estudos E Pesquisas Ltda, Campinas, SP, Brazil

🇧🇷

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda, Porto Alegre, RS, Brazil

and more 6 locations

Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

Phase 3
Completed
Conditions
Herpes Labialis
Interventions
First Posted Date
2010-12-09
Last Posted Date
2013-03-04
Lead Sponsor
EMS
Target Recruit Count
76
Registration Number
NCT01257074
Locations
🇧🇷

Flavia Addor, São Paulo, Brazil

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

A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)

Phase 1
Completed
Conditions
Neonatal Sepsis
Herpes Simplex Virus
Interventions
First Posted Date
2009-07-20
Last Posted Date
2019-01-08
Lead Sponsor
Phillip Brian Smith
Target Recruit Count
32
Registration Number
NCT00942084
Locations
🇺🇸

Tulane School of Medicine, New Orleans, Louisiana, United States

🇺🇸

Wesely Medical Center, Wichita, Kansas, United States

🇺🇸

Duke University, Durham, North Carolina, United States

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Phase 3
Completed
Conditions
Herpes Simplex
Interventions
First Posted Date
2009-03-04
Last Posted Date
2018-07-06
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
112
Registration Number
NCT00855309
Locations
🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Not Applicable
Completed
Conditions
Genital Herpes
Interventions
Drug: matching placebo
First Posted Date
2008-12-15
Last Posted Date
2013-12-11
Lead Sponsor
University of Washington
Target Recruit Count
88
Registration Number
NCT00808405
Locations
🇿🇦

Reproductive Health and HIV Research Unit (RHRU), Johannesburg, South Africa

🇿🇲

Center for Infectious Disease Research of Zambia (CIDRZ), Lusaka, Zambia

Phase 3 Clinical Study for the Treatment of Cold Sore

Phase 3
Completed
Conditions
Herpes Labialis
Interventions
First Posted Date
2008-10-09
Last Posted Date
2012-12-21
Lead Sponsor
Valerio Therapeutics
Target Recruit Count
1727
Registration Number
NCT00769314
Locations
🇵🇱

Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii, Gdynia, Poland

🇵🇱

Gabinet Internistyczny, Warszawa, Poland

🇵🇱

NZOZ Atopia, Al. J., Kraków, Poland

and more 46 locations

Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

Phase 3
Completed
Conditions
Herpes Labialis
Interventions
First Posted Date
2008-08-15
Last Posted Date
2008-08-15
Lead Sponsor
Medivir
Target Recruit Count
201
Registration Number
NCT00735761
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