SUMMARY
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analog active against herpesviruses. Acyclovir sodium for injection is a sterile lyophilized powder for intravenous administration only.
Herpes Simplex Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients.
Initial Episodes of Herpes Genitalis: ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients.
Herpes Simplex Encephalitis: ZOVIRAX for Injection is indicated for the treatment of herpes simplex encephalitis.
Neonatal Herpes Simplex Virus Infection: ZOVIRAX for Injection is indicated for the treatment of neonatal herpes infections.
Varicella-Zoster Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.
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NEWS HIGHLIGHTS
Published Studies Related to Zovirax Injection (Acyclovir)
Valacyclovir therapy does not reverse herpes-associated alterations in cervical
immunology: a randomized, placebo-controlled crossover trial. [2014]
Herpes simplex virus type 2 (HSV-2) infection is associated with a 3-fold
increase in the risk of human immunodeficiency virus (HIV) acquisition, perhaps
through alterations in mucosal HIV-susceptible target cells. We performed a
clinical trial to assess the impact of herpes therapy on cervical immunology in
HSV-2-infected, HIV-uninfected women from Africa or the Caribbean who were living
in Toronto, Canada.
A pilot study examining the safety and tolerability of valacyclovir in veterans
with hepatitis C virus/herpes simplex virus type 2 coinfection. [2014]
(HCV) coinfection... CONCLUSIONS: Valacyclovir 1 g twice daily showed no evidence of hepatotoxicity in
ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo-
and valacyclovir-controlled, dose-finding study. [2012]
replication... CONCLUSIONS: Three-day or single-day courses of ASP2151 appear to be effective
Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels
during pregnancy and postpartum: a randomized trial. [2012]
mother-to-child transmission (PMTCT) interventions is unknown... CONCLUSIONS: Valacyclovir significantly decreased early breast milk and plasma
Oral acyclovir suppression and neurodevelopment after neonatal herpes. [2011.10.06]
BACKGROUND: Poor neurodevelopmental outcomes and recurrences of cutaneous lesions remain unacceptably frequent among survivors of neonatal herpes simplex virus (HSV) disease... CONCLUSIONS: Infants surviving neonatal HSV disease with CNS involvement had improved neurodevelopmental outcomes when they received suppressive therapy with oral acyclovir for 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; CASG 103 and CASG 104 ClinicalTrials.gov numbers, NCT00031460 and NCT00031447, respectively.).
Clinical Trials Related to Zovirax Injection (Acyclovir)
Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2) [Completed]
The purpose of this study is to determine whether acyclovir is effective in suppressing HIV
viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are
starting HIV treatment for the first time.
Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV [Completed]
To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus
standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV
reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The
investigators hypothesize that high-dose valacyclovir will result in greater reduction in
plasma HIV-1 and genital HSV reactivation.
Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease [Recruiting]
Meniere's disease is a chronic illness that affects a substantial number of patients every
year worldwide. The disease is characterized by intermittent episodes of vertigo lasting
from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural
pressure. It has recently been suggested that viral etiologies specially Herpes virus might
be the underlying reason. The investigators study is a randomized, double- blinded
placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective
is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease
specially their vertigo attacks. Inclusion criteria would be patient's willingness to
participate in the study and follow ups, being 18 years old or older, having at least 2
vertigos per month each at least 20 min, interfering with function, and not on medication
for Meniere's disease for at least 3 months before the trial. They should not have any
history of allergy to Acyclovir, renal insufficiency or Creatinine above 1. 5 mg/dl, hepatic
enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing
or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2
different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take
the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a
day for the last 10 days. Patients will report changes in their symptoms 10 days after
initiating the drug and in 1, 3, 6 month intervals.
HSV-2 Shedding Resolution After Acyclovir Treatment [Completed]
The purpose of the study is to evaluate the pattern of viral shedding after beginning
treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with
the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth [Completed]
The purpose of this study is to test whether long-term treatment with oral acyclovir
improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes,
and mouth (SEM). Study participants will include infants in the United States and Canada who
have HSV disease of the skin, eyes, and mouth, with no central nervous system disease
present. Initially, all subjects will be treated with acyclovir administered through IV
access (through the vein) for 14 days while hospitalized. Participants will then be placed
in one of two groups, acyclovir given by mouth or a placebo (substance with no medication
present). The participant and the study site will not know to which group the subject is
assigned. All children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During
the follow up visits, physicals, hearing assessments, eye assessments, and neurological
assessments will be completed.
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Page last updated: 2014-11-30
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