Valaciclovir has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Valaciclovir Studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
104689 IV Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets –Single Oral Dose Study in Hemodialysis Patients
HS2100181 IV An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3
HS2100273 IV A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes
HS2100275 IV An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valaciclovir 1g Once Daily vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Subjects
HS240017 IV A Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate Daily Suppressive Therapy With VALTREX™ on the Rate of HSV Shedding in Subjects With Recurrent Genital Herpes
HS240018 IV A Randomized, Double-Blind, Multicenter Study of VALTREX 500mg Suppressive Therapy in the Reduction of Anxiety Associated with Recurrent Genital Herpes
HS240021 IV A Randomized, Double-Blind, Multicenter Study of VALTREX 500mg Suppressive Therapy in the Reduction of Anxiety Associated with Recurrent Genital Herpes
PREV123 IV Multicentre randomised trial comparing two strategies for the episodic use of valaciclovir, alone or combined with suppressive treatment in immunocompetent patients with recurrent genital herpes
VAL R24 IV A Double-Blind Study Comparing Two Doses of Valacyclovir HCL for the Treatment of Uncomplicated Herpes Zoster in Immunocompromised Patients 18 Years of Age and Older
VAL R94 IV An Open-Label Pilot Study of valacyclovir (VALTREX) 2000 mg BID for One Day in the Episodic Treatment of Recurrent Genital Herpes
VALF1005 IV Safety Follow-Up of the Association Valaciclovir-Mycophenolate Mofetil and Evaluation of the Potential Pharmacokinetic Interaction Between Valaciclovir and Mycophenolate Mofetil When They are Co-Administered in Renal Transplant Recipients
VALF1007 IV A pharmacokinetic study to evaluate the intra-ocular penetration of aciclovir following single, oral dose of valaciclovir in subjects undergoing cataract surgery.
VLX103596 IV A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects with No Previous History of Symptomatic Genital Herpes Infection
VLX105832 IV The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed with Genital Herpes Infection
WEUK-347 IV The Safety of Valacyclovir Among Severely Immunocompromised Patients with HIV-1/HSV-2 Co-Infection.
123-007 III A Comparative Trial of Valaciclovir and Aciclovir for the Suppression of Ano-Genital Herpes Infections in HIV-Infected Patients
123-008 III A Study to Investigate the Efficacy and Safety of Valaciclovir in the Treatment of Recurrent Ano-Genital Herpes in HIV-Infected Patients
123-014 (ACTG204) III A Randomised Double-Blind Trial of Valaciclovir (BW256U87) Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection (<100CD4+ Lymphocytes)
123-016 III 123-016: A Double-blind, Multi-centre Study Comparing Oral Valaciclovir and Aciclovir for the Suppression of CMV Infection and Disease Following Allogeneic Bone Marrow Transplantation
123-026 III A Comparative Trial of Valaciclovir With Aciclovir and Placebo for the Suppression of Recurrent Genital Herpes Infections in Immunocompetent Patients
123-033 III A randomized, double blind, placebo controlled cross over trial to compare valacyclovir HCl and acyclovir for suppression of subclinical herpes simplex virus shedding
123-037 III A Randomised, Double-Blind, Controlled Study of Valaciclovir for the Suppression of Recurrent Genital Herpes Simplex Virus Infection in Immunocompetent Patients
123-044 III Pharmacokinetics of valaciclovir in late pregnancy
123-304 III Zoster ophthalmicus in immunocompetent patients
123-310 III A double-blind, multicenter study comparing valacyclovir HCL with famciclovir for the treatment of uncomplicated herpes zoster in immunocompetent patients 50 years of age and older
HS2101951 III An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox.
HS230017 III An open-label, randomized, crossover study to determine subject treatment preference and efficacy of once daily valacyclovir 500 mg suppression therapy versus valacyclovir 500 mg twice daily treatment for recurrent genital HSV infections
HS230018 III An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
HS230027 III A Multicenter, Double-Blind, Placebo-Controlled Evaluation of Valaciclovir for the Reduction of the Length of Cold Sore Episodes
HS230028 III A Multicenter, Double-Blind, Placebo-Controlled Evaluation of Valaciclovir for the Prevention/Blockage of the Progression of Cold Sore Lesion Development
HS2A3005 III An Open-Label, Pilot Study to Estimate the Effect on Subject Survival and the Safety of CMV Prophylaxis with IV Acyclovir Followed by Valacyclovir Hydrochloride or Ganciclovir in Allogeneic Bone Marrow Transplant Recipients
HS2A4004 III A Comparison of Oral VALTREX 500mg Twice Daily for Three or Five Days for Treatment of Recurrent Genital Herpes
HS2AB3009 III A Randomized, Double-Blind, Placebo-Controlled Evaluation of Valaciclovir for the Prevention of Herpes Simplex Virus (HSV) Transmission in Heterosexual Couples (Double-Blind Phase and Open-Label Suppression Phase)
HS2B1001 III A study to compare the intraocular penetration of valaciclovir and aciclovir following multiple dose oral administration to patients undergoing cataract surgery.
HS2B3010 III A Randomized, Double-Blind Study to Compare Valaciclovir 500mg Twice Daily Given for Three Days With the Standard Five Day Course as Episodic Treatment for Recurrent Genital Herpes
HSV-003(JP) III Phase III Study of Valaciclovir Hydrochloride Tablets in Immunocompetent Patients With Herpes Simplex Virus Infections – Double-Blind Comparative With Aciclovir Tablets
P66/H73-005 III An International, Double-Blind, Controlled Trial Comparing Oral Acyclovir to Oral Valaciclovir for the Treatment of Herpes Zoster in Immunocompetent Patients 50 Years of Age or Older
P66/H73-006 III A Multicenter, Double-Blind, Placebo-Controlled Trial Evaluating Oral Valaciclovir for the Treatment of Herpes Zoster in Immunocompetent Patients Less Than 50 Years Old
P66/H73-012 (Pharmacokinetics) III Pharmacokinetic Analysis: Oral 256U87 Safety, Pharmacokinetics, and Prophylaxis of Cytomegalovirus Infection and Disease in Renal Allograft Recipients
P66/H73-012 (CMV Seronegative Recipients) III Oral 256U87 (Valaciclovir) Safety, Pharmacokinetics and Suppression of Cytomegalovirus Infection and Disease in Renal Allograft Recipients
P66/H73-012 (CMV Seropositive Recipients) III Oral 256U87 (Valaciclovir) Safety, Pharmacokinetics and Suppression of Cytomegalovirus Infection and Disease in Renal Allograft Recipients
P66-H73-003 (123-003) III A Comparative Trial of Valacyclovir and Acyclovir for the Treatment of First-Episode Genital Herpes Infection
U87TH-04 III Clinical Effect of Valaciclovir Hydrochloride (256U87) Tablets in Patients With Genital Herpes
VALF 3002 III Multicentre, randomised, open-label study to compare the efficacy and safety of valaciclovir oral route and aciclovir intravenous route, to treat zoster in immunodeficient patients.
VAL-R19 III A Single-Center, Open-Label Study of the Safety and Pharmacokinetics of Valacyclovir in Children with Epstein-Barr Virus Illness
VAL-R56 III Acyclovir Concentrations in Human Breast Milk After Valaciclovir Administration
123-031 II A Pilot, Randomized, Double-Blind Study to Investigate the use of Valaciclovir for the Prophylaxis of CMV Infection in Recipients of a Heart or Single Lung Transplant
123(H73)-013-V I The Pharmacokinetics of Valaciclovir and Acyclovir After Oral Administration of a Single Dose of Valaciclovir to Patients With Cirrhosis and Healthy Volunteers
123-034 I Report of the Pharmacokinetics of Aciclovir and Digoxin Following Administration of Digoxin and Valaciclovir Alone and in Combination to Healthy Volunteers
123-038 I Evaluation of the Effect of an Aluminium Hydroxide and Magnesium Hydroxide Containing Antacid on the Pharmacokinetics of Valaciclovir and Acyclovir Following a Single Oral Dose of Valaciclovir
H73-020-V I The Effects of Probenecid and Cimetidine on the Pharmacokinetics of Valaciclovir and its Metabolite Acyclovir in Healthy Male Volunteers
HS210909 I Report of a Study to Evaluate the Bioequivalence of Single Doses of an Investigational Formulation of Valaciclovir Compared to the Standard Valaciclovir Tablet in Healthy Volunteers
HS210914 I An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children
HS210915 I An open-label, multiple-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection
HS210916 I An open-label, multiple-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children with VZV infection
HS240016 I CSF Penetration of Acyclovir and its Metabolites After High Dose Valacyclovir Administration
HS2B4001 I A Pharmacokinetic Study to Compare Aciclovir Plasma Exposures Attained with IV Zovirax® 5mg/kg t.d.s and Oral Valtrex® 1000mg t.d.s. in Neutropenic Non-HIV Patients
HS2B4005 I An Investigation of the Steady-State Pharmacokinetics of Oral Valacyclovir in Immunocompromised Children
P66-09 (123-009) I Single-Dose Pharmacokinetics and Safety of Valaciclovir in Volunteers with End-Stage Renal Disease
P66-10 I Pharmacokinetics and Safety of Acyclovir and Valaciclovir Following Single and Multiple Oral Administration of Valaciclovir in Geriatric Volunteers With and Without Concomitant Diuretic Therapy
VALF1004 I Safety Follow-Up of the Association Valaciclovir –Tacrolimus and Evaluation of the Potential Pharmacokinetic Interaction Between Valaciclovir and Tacrolimus When They are Co-Administered in Renal Transplant Recipients
VALF1006/HS210911 I A Randomised, Open-Label, Cross-Over, Single Dose Study to Evaluate the Pharmacokinetic Interaction Between Aciclovir 800mg and Mycophenolate Mofetil 1000mg and Between Valaciclovir 2000mg and Mycophenolate Mofetil 1000mg in Healthy Volunteers