Acyclovir

Generic Name: Acyclovir

Brand Names: Sitavig, Xerese, Zovirax

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₁N_₅O_₃

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

Clinical Trials

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

Phase 3

Active, not recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Alemtuzumab GZ402673
Drug: Glatiramer acetate
Drug: Beta-Interferon
Drug: Methylprednisolone
Drug: Ranitidine
Drug: Ceterizine
Drug: Dexchlorpheniramine
Drug: Paracetamol
Drug: Acyclovir
Drug: Prednisolone
Drug: Diphenydramine
Drug: Other H1 antagonist

First Posted Date: 2017-12-11

Last Posted Date: 2023-09-21

Lead Sponsor: Genzyme, a Sanofi Company

Target Recruit Count: 16

Registration Number: NCT03368664

Locations: 🇹🇷
Investigational Site Number :7920002, Ankara, Turkey
🇹🇷
Investigational Site Number :7920001, Ankara, Turkey
🇫🇷
Investigational Site Number :2500002, Strasbourg, France

and more 18 locations

A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Phase 1

Recruiting

Conditions: Age-Related Macular Degeneration

Interventions: Drug: ASP7317
Drug: tacrolimus
Drug: trimethoprim-sulfamethoxazole
Drug: Acyclovir
Drug: Nystatin

First Posted Date: 2017-06-06

Last Posted Date: 2025-05-20

Lead Sponsor: Astellas Institute for Regenerative Medicine

Target Recruit Count: 42

Registration Number: NCT03178149

Locations: 🇺🇸
Retinal Consultants of Arizona LTD, Retinal Research Institute, Phoenix, Arizona, United States
🇺🇸
Jules Stein Eye Institute, Los Angeles, California, United States
🇺🇸
Stanford University Byers Eye Institute, Palo Alto, California, United States

and more 13 locations

Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

Phase 2

Completed

Conditions: Stem Cell Transplant Complications

Interventions: Drug: Levofloxacin 500Mg Oral Tablet
Drug: Zinc Sulfate Oral Product
Drug: Fluconazole 200mg tab
Drug: Acyclovir 400 MG

First Posted Date: 2017-05-19

Last Posted Date: 2020-01-07

Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Target Recruit Count: 20

Registration Number: NCT03159845

Locations: 🇮🇹
Hematology UO, Pisa, Italy

A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Phase 1

Completed

Conditions: Progressive Multiple Sclerosis

Interventions: Drug: GZ402668
Drug: Placebo
Drug: Acyclovir

First Posted Date: 2016-11-30

Last Posted Date: 2022-04-25

Lead Sponsor: Sanofi

Target Recruit Count: 20

Registration Number: NCT02977533

Locations: 🇩🇪
Investigational Site Number 276001, Berlin, Germany

Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes

Phase 2

Completed

Conditions: Herpes Labialis

Interventions: Drug: Pritelivir 5% w/w ointment
Drug: Pritelivir ointment matching placebo
Drug: Zovirax® cream

First Posted Date: 2016-08-18

Last Posted Date: 2021-07-13

Lead Sponsor: AiCuris Anti-infective Cures AG

Target Recruit Count: 362

Registration Number: NCT02871492

Bioequivalence of Topical Acyclovir in Healthy Volunteers

Not Applicable

Completed

Conditions: Dermatologic Disorders

Interventions: Drug: 5% Zovirax® cream
Drug: 5% Aciclostad cream
Drug: 5% Aciclovir cream 1A Pharma
Device: OFM Probe
Drug: 5% Zovirax Cold Sore Cream
Drug: 5% Zovirax® cream (Austria)
Procedure: OFM
Device: OFM Pump

First Posted Date: 2016-03-17

Last Posted Date: 2016-03-17

Lead Sponsor: Medical University of Graz

Target Recruit Count: 36

Registration Number: NCT02711267

Locations: 🇦🇹
Medical University Graz, Graz, Styria, Austria

A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis

Phase 1

Completed

Conditions: Progressive Multiple Sclerosis

Interventions: Drug: Acyclovir
Drug: Methylprednisolone
Drug: alemtuzumab GZ402673
Drug: Paracetamol
Drug: Loratadine
Drug: Ceterizine
Drug: Dexchlorpheniramine

First Posted Date: 2015-10-22

Last Posted Date: 2021-03-10

Lead Sponsor: Genzyme, a Sanofi Company

Target Recruit Count: 24

Registration Number: NCT02583594

Locations: 🇪🇸
Investigational Site Number 724001, Barcelona, Spain

Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores

Phase 2

Completed

Conditions: Herpes Labialis

Interventions: Drug: Acyclovir cream 5%
Drug: ZEP-3 ointment 1.0%

First Posted Date: 2015-06-26

Last Posted Date: 2019-05-30

Lead Sponsor: Shulov Innovate for Science Ltd. 2012

Target Recruit Count: 210

Registration Number: NCT02483182

Locations: 🇮🇱
Dermatology out-patients clinic, Lev Hayasmin MC, Netanya, Israel

Antiviral Prophylaxis in a Burn Population

Phase 2

Withdrawn

Conditions: Herpes Simplex

Interventions: Drug: Acyclovir

First Posted Date: 2015-01-29

Last Posted Date: 2016-04-21

Lead Sponsor: Southern Illinois University

Registration Number: NCT02349828

Locations: 🇺🇸
Southern Illinois University School of Medicine, Springfield, Illinois, United States

Aseptic Meningoencephalitis in Slovenia

Conditions: Aseptic Meningitis

Interventions: Drug: symptomatic therapy
Drug: Ceftriaxone or Doxycycline
Other: questionnaire
Drug: Acyclovir

First Posted Date: 2014-12-31

Last Posted Date: 2018-05-04

Lead Sponsor: University Medical Centre Ljubljana

Target Recruit Count: 800

Registration Number: NCT02328469

Locations: 🇸🇮
UMC Ljubljana, Department of Infectious Diseases, Ljubljana, Slovenia
🇸🇮
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia, Ljubljana, Slovenia

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