Valacyclovir Clinical Trials (2026): 111 Studies for Herpes Simplex & HIV Infections
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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111 Valacyclovir clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 69 indications (including Herpes Simplex & HIV Infections) and 12,349 total planned enrollment. 13 Phase 3 Valacyclovir trials and 32 Phase 2, 17 Phase 4 are listed. 10 Valacyclovir clinical trials are actively recruiting at 12 U.S. sites across 10 states. Most recent activity: NCT06914479 (May 2031).
Where to Participate: All Valacyclovir Trial Sites in the U.S. (12 sites across 10 states)
Every actively recruiting Valacyclovirtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Academic Urology and Urogynecology of Arizona | Peoria85381 | NCT07332000 | Map |
| CA | UCSF Dental | San Francisco94143 | NCT05266040 | Map |
| CO | Colorado Clinical Research | Lakewood80228 | NCT07332000 | Map |
| CO | Urology Associates | Littleton80122 | NCT07332000 | Map |
| MD | Chesapeake Urology Research Associates | Towson21204 | NCT07332000 | Map |
| MI | University of Michigan Comprehensive Cancer Center | Ann Arbor48109 | NCT06914479 | Map |
| NV | Sheldon Freedman, MD Ltd. | Las Vegas89144 | NCT07332000 | Map |
| NJ | Summit Health | Saddle Brook07663 | NCT07332000 | Map |
| SC | START Carolinas | Myrtle Beach29572 | NCT07332000 | Map |
| TN | Vanderbilt University Medical Center | Nashville37129 | NCT05550194 | Map |
| TX | Houston Methodist | Houston77030 | NCT01913106 | Map |
| TX | M D Anderson Cancer Center | Houston77030 | NCT05536349 | Map |
Valacyclovir clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | enrolling by invitation | completed | terminated | withdrawn | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | |||||||
| P1 | 1 | 19 | 1 | 1 | 3 | 25 | |||
| P1/P2 | 1 | 1 | 2 | ||||||
| P2 | 3 | 2 | 1 | 22 | 2 | 1 | 1 | 32 | |
| P2/P3 | 1 | 1 | |||||||
| P3 | 1 | 1 | 9 | 1 | 1 | 13 | |||
| P4 | 1 | 12 | 2 | 1 | 1 | 17 | |||
| N/A | 1 | 16 | 1 | 2 | 20 |
Recruiting Valacyclovir clinical trials (10)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06914479 | Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors | P1 | Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant | 11 | May 2026 |
| NCT07294547 | Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study | N/A | Kidney Transplantation, Cytomegalovirus Infections | 80 | Nov 2025 |
| NCT05446571 | CYMEVAL3-step2Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir | P3 | Pregnant Women | 46 | Oct 2023 |
| NCT01913106 | HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer | P1/P2 | Prostatic Neoplasms | 25 | Jun 2007 |
| NCT07597902 | SHIELDSARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction | P2 | Post-acute Sequelae of COVID-19 | 150 | Jun 2026 |
| NCT05536349 | CLLTime-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) | P2 | Leukemia | 60 | Dec 2022 |
| NCT07363031 | Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy | P2 | Oral Mucositis | 84 | Sep 2022 |
| NCT07332000 | A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec | P2 | Prostate Cancer Patients Treated by Radiotherapy | 45 | Oct 2025 |
| NCT05550194 | VZV in the Enteric Nervous System: Pathogenesis and Consequences | P4 | Achalasia | 40 | Mar 2023 |
| NCT05266040 | Valacyclovir in Pain Management of Acute Apical Abscesses | P2 | Acute Apical Abscess | 60 | Oct 2023 |
Valacyclovir clinical trials by indication
Herpes Simplex (9)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05468619 | — | P1 | completed | Neonatal Phase 1 Valacyclovir Study |
| NCT01794897 | — | P4 | completed | Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia |
| NCT00587496 | — | P1 | unknown | 30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers |
| NCT00161434 | — | P4 | completed | A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons |
| NCT00002404 | — | N/A | completed | The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients |
| NCT00002084 | — | N/A | completed | A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients |
| NCT00002000 | — | N/A | completed | A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients |
| NCT00001054 | — | P1 | withdrawn | The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children |
| + 1 more, see All trials below. | ||||
Herpes Zoster (9)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05492591 | — | P2 | completed | A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster |
| NCT02152800 | Vacyless® | P4 | completed | A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster |
| NCT00900783 | — | P2 | completed | A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster |
| NCT00831103 | — | P2 | completed | A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster |
| NCT00487682 | — | P2 | completed | Dose-finding Study of ASP2151 in Subjects With Herpes Zoster |
| NCT01250561 | — | N/A | completed | Reduction of Postherpetic Neuralgia in Herpes Zoster |
| NCT01132716 | — | N/A | completed | Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions |
| NCT01132729 | — | N/A | completed | Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions |
| + 1 more, see All trials below. | ||||
Healthy (9)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01222897 | — | N/A | completed | A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition |
| NCT01222910 | — | N/A | completed | A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition |
| NCT01136525 | — | P1 | completed | Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions |
| NCT01136538 | — | P1 | completed | Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition |
| NCT00650494 | — | P1 | completed | Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg |
| NCT00649870 | — | P1 | completed | Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg |
| NCT00649974 | — | P1 | completed | Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg |
| NCT01149499 | — | P1 | completed | Valacyclovir 1000 mg Tablet Under Fasting Conditions |
| + 1 more, see All trials below. | ||||
Genital Herpes (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01658826 | — | P2 | terminated | Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes |
| NCT01346475 | — | P4 | completed | Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 |
| NCT00362297 | — | P4 | completed | Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 |
| NCT00527618 | HSV-2 | P4 | completed | Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV |
| NCT00306787 | — | P3 | completed | Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes |
Malignant Glioma (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00634231 | — | P1 | completed | A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors |
| NCT00589875 | BrTK02 | P2 | completed | Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma |
| NCT00751270 | BrTK01 | P1 | completed | Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas |
Herpes Genitalis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00486200 | — | P2 | completed | A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes |
| NCT00158509 | — | P2 | completed | Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding |
| NCT00079911 | — | P4 | terminated | A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons |
Acute Apical Abscess (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05266040 | — | P2 | recruiting | Valacyclovir in Pain Management of Acute Apical Abscesses |
| NCT06344195 | Antiviral | P4 | unknown | Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening |
Prostate Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01436968 | PrTK03 | P3 | active not recruiting | Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer |
| NCT02768363 | ULYSSES | P2 | active not recruiting | Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) |
Shingles (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02412917 | — | P3 | terminated | A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia |
| NCT00059592 | — | P1 | completed | Valacyclovir in Immunocompromised Children |
Schizophrenia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02008773 | VISTA | P2 | completed | A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia |
| NCT00514449 | SEAMS | P2 | completed | Systematic Evaluation of Antiviral Medication in Schizophrenia |
Varicella Zoster Virus Infection (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01682109 | VALID-0 | P4 | completed | Palatability Testing of a New Paediatric Formulation of Valacyclovir |
| NCT01689285 | VALID-I | P1 | completed | Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir |
Chronic Hepatitis C Infection (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01453075 | — | P1 | completed | Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I) |
| NCT01580995 | HSV1/HCV | P2 | completed | Herpes Simplex Type 1 Suppression in Hepatitis C |
HIV Infection (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00860977 | VALIDATE | P3 | completed | Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? |
| NCT00378976 | — | P3 | completed | HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men. |
HIV (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00803543 | — | N/A | completed | Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding |
| NCT01059084 | — | N/A | withdrawn | An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons |
HIV Infections (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00530777 | VIP | P2 | completed | HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding |
| NCT00465205 | — | P3 | completed | HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons |
Herpes Labialis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00297011 | — | P2 | completed | Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis |
| NCT00306293 | — | P4 | completed | VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 |
Post-acute Sequelae of COVID-19 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07597902 | SHIELD | P2 | not yet recruiting | SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction |
Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06914479 | — | P1 | recruiting | Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors |
Kidney Transplantation, Cytomegalovirus Infections (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07294547 | — | N/A | recruiting | Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study |
Prostate Cancer Patients Treated by Radiotherapy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07332000 | — | P2 | recruiting | A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec |
Symptomatic Apical Periodontitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07014397 | — | N/A | completed | Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth |
Pregnant Women (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05446571 | CYMEVAL3-step2 | P3 | recruiting | Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir |
Long COVID (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06316843 | PASC | P2 | completed | Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 |
Severe Periodontitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05712343 | — | Early P1 | unknown | The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis |
Achalasia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05550194 | — | P4 | recruiting | VZV in the Enteric Nervous System: Pathogenesis and Consequences |
Postherpetic Neuralgia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07349680 | — | P3 | completed | Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia |
Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05536349 | CLL | P2 | recruiting | Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) |
Oral Mucositis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07363031 | — | P2 | enrolling by invitation | Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy |
Neonatal Herpes Simplex Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04448392 | — | P1 | completed | Valacyclovir in Neonatal Herpes Simplex Virus Disease |
Pain, Chronic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05094414 | VARIC | P1 | unknown | Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS |
Bile Salt Export Pump (BSEP) Transporter (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04640571 | — | P4 | completed | Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition |
Mild Cognitive Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04710030 | VALMCI | P2 | completed | Valacyclovir for Mild Cognitive Impairment |
Herpes Simplex Virus Keratitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03626376 | HSV | P4 | withdrawn | Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis |
Herpes Simplex Virus Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04081480 | VALID2 | N/A | terminated | Pharmacokinetics of Valacyclovir Oral Solution in Children |
High-risk Prostate Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03541928 | — | P2 | unknown | Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery |
Glioma, Malignant (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03576612 | GMCI | P1 | completed | GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas |
Alzheimer Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03282916 | — | P2 | completed | Anti-viral Therapy in Alzheimer's Disease |
Herpes (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04664127 | HSV | N/A | completed | Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel |
Herpes Zoster Ophthalmicus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03134196 | ZEDS | P4 | completed | Zoster Eye Disease Study |
Metastatic Non-small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03004183 | STOMP | P2 | completed | SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC |
Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03131037 | — | P1 | completed | Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer |
Lung Squamous Cell Carcinoma Stage IV (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02831933 | ENSIGN | P2 | terminated | Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma |
Herpetic Gingivostomatitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02738229 | — | P2 | completed | Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? |
Acne Scars - Mixed Atrophic and Hypertrophic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03514771 | — | N/A | completed | Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin |
Congenital Cytomegalovirus Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02351102 | — | P2/P3 | completed | Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy |
Herpes Simplex Virus 2 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02571166 | — | P1 | completed | HSV529 Vaccine in HSV-2 Seropositive Adults |
Transplantation Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01972035 | — | P2 | completed | ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation |
Malignant Pleural Effusion (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01997190 | MpeTK01 | P1 | completed | Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion |
Foetuses Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01651585 | CYMEVAL2 | P4 | completed | In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir |
Human Immunodeficiency Virus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01176409 | VALIANT Pilot | P3 | completed | Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2? |
Herpes Simplex Type Two Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00946556 | HSV2 | N/A | completed | Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix |
Hepatitis C Virus Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01037621 | — | P1 | unknown | Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C |
HSV Infection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01026454 | ACV-VAL | P4 | completed | Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons |
Viral Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01037712 | CYMEVAL | P4 | terminated | In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir |
Safety of ASP2151 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00870441 | — | P1 | terminated | Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers |
Bacterial Vaginosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00682721 | — | N/A | withdrawn | Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women |
Pancreatic Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00638612 | PaTK01 | P1 | completed | AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01) |
Prostatic Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01913106 | — | P1/P2 | recruiting | HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer |
Bipolar Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00428298 | — | P2 | completed | Research Study of Bipolar Mood Symptoms and Cognitive Problems |
Waldenstrom's Macroglobulinemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00492050 | — | P2 | active not recruiting | Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia |
Psychosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00175513 | V3 | P2 | completed | V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis |
Infectious Mononucleosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00274404 | — | P1/P2 | completed | Controlled Trial of Valacyclovir in Infectious Mononucleosis |
Chronic Lymphocytic Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00562770 | — | P2 | completed | Oral Valganciclovir Versus Valacyclovir |
Bell´s Palsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00561106 | PVBP | N/A | completed | Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy |
Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00045292 | — | P3 | completed | Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation |
Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00042328 | — | P2 | completed | A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients |
Encephalitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00031486 | HSE | P3 | completed | Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir |
Bell's Palsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01686464 | — | N/A | completed | A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy |
Cytomegalovirus Infections (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00001038 | — | P3 | completed | A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients |
Valacyclovir pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ZEDS | NCT03134196 | P4 | completed | Herpes Zoster Ophthalmicus | 527 | PMID 40048191 |
| Antiviral | NCT06344195 | P4 | unknown | Acute Apical Abscess | 82 | — |
| HSV | NCT03626376 | P4 | withdrawn | Herpes Simplex Virus Keratitis | 0 | — |
| VALID-0 | NCT01682109 | P4 | completed | Varicella Zoster Virus Infection | 41 | PMID 28800385 |
| CYMEVAL2 | NCT01651585 | P4 | completed | Foetuses Infection | 41 | PMID 27083761 |
| Vacyless® | NCT02152800 | P4 | completed | Herpes Zoster | 25 | — |
| CYMEVAL | NCT01037712 | P4 | terminated | Viral Disease | 6 | — |
| HSV-2 | NCT00527618 | P4 | completed | Genital Herpes | 28 | — |
| ACV-VAL | NCT01026454 | P4 | completed | HSV Infection | 32 | PMID 21998479 |
| PrTK03 | NCT01436968 | P3 | active not recruiting | Prostate Cancer | 711 | — |
| CYMEVAL3-step2 | NCT05446571 | P3 | recruiting | Pregnant Women | 46 | — |
| VALIDATE | NCT00860977 | P3 | completed | HIV Infection | 202 | PMID 21106086 |
| VALIANT Pilot | NCT01176409 | P3 | completed | Human Immunodeficiency Virus | 60 | PMID 23946220 |
| HSE | NCT00031486 | P3 | completed | Encephalitis | 91 | PMID 25956891 |
| SHIELD | NCT07597902 | P2 | not yet recruiting | Post-acute Sequelae of COVID-19 | 150 | — |
| CLL | NCT05536349 | P2 | recruiting | Leukemia | 60 | — |
| ULYSSES | NCT02768363 | P2 | active not recruiting | Prostate Cancer | 187 | — |
| VALMCI | NCT04710030 | P2 | completed | Mild Cognitive Impairment | 50 | — |
| PASC | NCT06316843 | P2 | completed | Long COVID | 59 | — |
| STOMP | NCT03004183 | P2 | completed | Metastatic Non-small Cell Lung Cancer | 57 | — |
| ENSIGN | NCT02831933 | P2 | terminated | Lung Squamous Cell Carcinoma Stage IV | 11 | — |
| VISTA | NCT02008773 | P2 | completed | Schizophrenia | 170 | PMID 30478008 |
| SEAMS | NCT00514449 | P2 | completed | Schizophrenia | 31 | PMID 22446565 |
| BrTK02 | NCT00589875 | P2 | completed | Malignant Glioma | 52 | PMID 26843484 |
| HSV1/HCV | NCT01580995 | P2 | completed | Chronic Hepatitis C Infection | 19 | — |
| VIP | NCT00530777 | P2 | completed | HIV Infections | 148 | PMID 22852760 |
| V3 | NCT00175513 | P2 | completed | Psychosis | 100 | — |
Terminated and withdrawn Valacyclovir trials (11)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT03626376withdrawnTopical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
- NCT04081480terminatedPharmacokinetics of Valacyclovir Oral Solution in Children
- NCT02831933terminatedTrial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma
- NCT02412917terminatedA Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
- NCT01658826terminatedSafety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
- NCT01059084withdrawnAn Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
- NCT01037712terminatedIn UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
- NCT00682721withdrawnValacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
- NCT00870441terminatedStudy Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
- NCT00079911terminatedA Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
- NCT00001054withdrawnThe Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
All Valacyclovir trials (111)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06914479 | Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors | P1 | recruiting | 11 | University of Michigan Rogel Cancer Center | May 2026 | |
| NCT07294547 | Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study | N/A | recruiting | 80 | National Taiwan University Hospital | Nov 2025 | |
| NCT01436968 | PrTK03 | Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer | P3 | active not recruiting | 711 | Candel Therapeutics, Inc. | Sep 2011 |
| NCT05446571 | CYMEVAL3-step2 | Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir | P3 | recruiting | 46 | Assistance Publique - Hôpitaux de Paris | Oct 2023 |
| NCT01913106 | HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer | P1/P2 | recruiting | 25 | The Methodist Hospital Research Institute | Jun 2007 | |
| NCT07597902 | SHIELD | SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction | P2 | not yet recruiting | 150 | Icahn School of Medicine at Mount Sinai | Jun 2026 |
| NCT05536349 | CLL | Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) | P2 | recruiting | 60 | M.D. Anderson Cancer Center | Dec 2022 |
| NCT02768363 | ULYSSES | Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) | P2 | active not recruiting | 187 | Candel Therapeutics, Inc. | May 2016 |
| NCT07363031 | Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy | P2 | enrolling by invitation | 84 | Instituto Oncoclinicas | Sep 2022 | |
| NCT07332000 | A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec | P2 | recruiting | 45 | Candel Therapeutics, Inc. | Oct 2025 | |
| NCT05550194 | VZV in the Enteric Nervous System: Pathogenesis and Consequences | P4 | recruiting | 40 | Vanderbilt University Medical Center | Mar 2023 | |
| NCT00492050 | Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia | P2 | active not recruiting | 46 | M.D. Anderson Cancer Center | Aug 2006 | |
| NCT05266040 | Valacyclovir in Pain Management of Acute Apical Abscesses | P2 | recruiting | 60 | University of California, San Francisco | Oct 2023 | |
| NCT07349680 | Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia | P3 | completed | 100 | Assiut University | Mar 2023 | |
| NCT05468619 | Neonatal Phase 1 Valacyclovir Study | P1 | completed | 17 | National Institute of Allergy and Infectious Diseases (NIAID) | Aug 2023 | |
| NCT07014397 | Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth | N/A | completed | 38 | Tehran University of Medical Sciences | Nov 2024 | |
| NCT04710030 | VALMCI | Valacyclovir for Mild Cognitive Impairment | P2 | completed | 50 | New York State Psychiatric Institute | Feb 2021 |
| NCT06316843 | PASC | Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 | P2 | completed | 59 | Bateman Horne Center | Oct 2023 |
| NCT03282916 | Anti-viral Therapy in Alzheimer's Disease | P2 | completed | 120 | Columbia University | Feb 2018 | |
| NCT04448392 | Valacyclovir in Neonatal Herpes Simplex Virus Disease | P1 | completed | 7 | University of Alabama at Birmingham | Jul 2021 | |
| NCT03134196 | ZEDS | Zoster Eye Disease Study | P4 | completed | 527 | NYU Langone Health | Aug 2017 |
| NCT06344195 | Antiviral | Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening | P4 | unknown | 82 | Dow University of Health Sciences | Mar 2024 |
| NCT05712343 | The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis | Early P1 | unknown | 40 | University of California, San Francisco | May 2023 | |
| NCT03004183 | STOMP | SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC | P2 | completed | 57 | The Methodist Hospital Research Institute | Jul 2017 |
| NCT03131037 | Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer | P1 | completed | 12 | Candel Therapeutics, Inc. | May 2017 | |
| NCT03541928 | Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery | P2 | unknown | 60 | The Methodist Hospital Research Institute | Aug 2018 | |
| NCT05492591 | A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster | P2 | completed | 50 | Shanghai Institute Of Biological Products | Oct 2022 | |
| NCT03576612 | GMCI | GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas | P1 | completed | 41 | Candel Therapeutics, Inc. | Feb 2018 |
| NCT02738229 | Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? | P2 | completed | 80 | St. Justine's Hospital | Jul 2016 | |
| NCT05094414 | VARIC | Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS | P1 | unknown | 30 | Buddhist Tzu Chi General Hospital | Jul 2021 |
| NCT03626376 | HSV | Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis | P4 | withdrawn | 0 | NYU Langone Health | Dec 2019 |
| NCT04640571 | Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition | P4 | completed | 18 | University of Maryland, Baltimore | Apr 2021 | |
| NCT00634231 | A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors | P1 | completed | 8 | Candel Therapeutics, Inc. | Oct 2010 | |
| NCT04081480 | VALID2 | Pharmacokinetics of Valacyclovir Oral Solution in Children | N/A | terminated | 7 | Radboud University Medical Center | Dec 2019 |
| NCT01972035 | ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation | P2 | completed | 137 | University of Minnesota | Aug 2014 | |
| NCT02831933 | ENSIGN | Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma | P2 | terminated | 11 | Eric Bernicker, MD | Feb 2017 |
| NCT02351102 | Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy | P2/P3 | completed | 100 | Rabin Medical Center | Nov 2015 | |
| NCT02571166 | HSV529 Vaccine in HSV-2 Seropositive Adults | P1 | completed | 10 | Fred Hutchinson Cancer Center | Nov 2015 | |
| NCT04664127 | HSV | Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel | — | completed | 45 | Nearmedic Plus LLC | Oct 2017 |
| NCT01997190 | MpeTK01 | Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion | P1 | completed | 19 | Candel Therapeutics, Inc. | Oct 2013 |
| NCT02412917 | A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia | P3 | terminated | 237 | ContraVir Pharmaceuticals, Inc. | Jun 2015 | |
| NCT02008773 | VISTA | A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia | P2 | completed | 170 | Indiana University | Mar 2014 |
| NCT03514771 | Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin | N/A | completed | 15 | David Smart | Jan 2016 | |
| NCT01794897 | Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia | P4 | completed | 134 | University of Pittsburgh | Feb 2013 | |
| NCT00514449 | SEAMS | Systematic Evaluation of Antiviral Medication in Schizophrenia | P2 | completed | 31 | Konasale Prasad | Jun 2007 |
| NCT00589875 | BrTK02 | Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma | P2 | completed | 52 | Candel Therapeutics, Inc. | Mar 2007 |
| NCT01682109 | VALID-0 | Palatability Testing of a New Paediatric Formulation of Valacyclovir | P4 | completed | 41 | Radboud University Medical Center | Sep 2012 |
| NCT01453075 | Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I) | P1 | completed | 31 | VA Office of Research and Development | Nov 2011 | |
| NCT00860977 | VALIDATE | Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? | P3 | completed | 202 | University Health Network, Toronto | Mar 2010 |
| NCT01689285 | VALID-I | Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir | P1 | completed | 16 | Radboud University Medical Center | Dec 2013 |
| NCT01651585 | CYMEVAL2 | In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir | P4 | completed | 41 | Assistance Publique - Hôpitaux de Paris | Jul 2011 |
| NCT00638612 | PaTK01 | AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01) | P1 | completed | 27 | Candel Therapeutics, Inc. | Aug 2008 |
| NCT01580995 | HSV1/HCV | Herpes Simplex Type 1 Suppression in Hepatitis C | P2 | completed | 19 | VA Office of Research and Development | Apr 2012 |
| NCT00803543 | Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding | N/A | completed | 103 | University of Alabama at Birmingham | Jan 2009 | |
| NCT02152800 | Vacyless® | A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster | P4 | completed | 25 | Yung Shin Pharm. Ind. Co., Ltd. | Apr 2011 |
| NCT01176409 | VALIANT Pilot | Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2? | P3 | completed | 60 | University Health Network, Toronto | Sep 2010 |
| NCT01658826 | Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes | P2 | terminated | 91 | AiCuris Anti-infective Cures AG | Oct 2012 | |
| NCT01059084 | An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons | N/A | withdrawn | 0 | University of Washington | Jan 2010 | |
| NCT00428298 | Research Study of Bipolar Mood Symptoms and Cognitive Problems | P2 | completed | 60 | Johns Hopkins University | Mar 2007 | |
| NCT01037621 | Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C | P1 | unknown | 50 | G.V. (Sonny) Montgomery VA Medical Center | Apr 2010 | |
| NCT01346475 | Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 | P4 | completed | 50 | University of Washington | Nov 2008 | |
| NCT00362297 | Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 | P4 | completed | 31 | University of Washington | Sep 2006 | |
| NCT01037712 | CYMEVAL | In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir | P4 | terminated | 6 | Assistance Publique - Hôpitaux de Paris | Sep 2009 |
| NCT00946556 | HSV2 | Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix | N/A | completed | 30 | University of Toronto | Apr 2010 |
| NCT00527618 | HSV-2 | Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV | P4 | completed | 28 | University of Washington | Dec 2007 |
| NCT00031486 | HSE | Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir | P3 | completed | 91 | National Institute of Allergy and Infectious Diseases (NIAID) | Sep 2000 |
| NCT00751270 | BrTK01 | Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas | P1 | completed | 15 | Candel Therapeutics, Inc. | Nov 2005 |
| NCT01026454 | ACV-VAL | Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons | P4 | completed | 32 | University of Washington | Feb 2010 |
| NCT00900783 | A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster | P2 | completed | 350 | Bristol-Myers Squibb | May 2009 | |
| NCT00682721 | Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women | N/A | withdrawn | 0 | University of Pittsburgh | Feb 2009 | |
| NCT00530777 | VIP | HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding | P2 | completed | 148 | University of Washington | Apr 2008 |
| NCT00870441 | Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers | P1 | terminated | 442 | Astellas Pharma Inc | Mar 2009 | |
| NCT00175513 | V3 | V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis | P2 | completed | 100 | University of British Columbia | Sep 2005 |
| NCT01222897 | A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition | N/A | completed | 40 | Ranbaxy Laboratories Limited | May 2009 | |
| NCT01222910 | A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition | N/A | completed | 36 | Ranbaxy Laboratories Limited | May 2009 | |
| NCT00831103 | A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster | P2 | completed | 373 | Epiphany Biosciences | Nov 2007 | |
| NCT00487682 | Dose-finding Study of ASP2151 in Subjects With Herpes Zoster | P2 | completed | 403 | Astellas Pharma Inc | Nov 2007 | |
| NCT00486200 | A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes | P2 | completed | 695 | Astellas Pharma Inc | Jun 2007 | |
| NCT00587496 | 30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers | P1 | unknown | 60 | National Eye Institute (NEI) | Apr 2006 | |
| NCT00306787 | Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes | P3 | completed | 1,179 | Novartis Pharmaceuticals | Mar 2006 | |
| NCT00297011 | Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis | P2 | completed | 300 | University of Utah | Sep 2004 | |
| NCT00465205 | HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons | P3 | completed | 20 | University of Washington | Jan 2005 | |
| NCT01250561 | Reduction of Postherpetic Neuralgia in Herpes Zoster | N/A | completed | 133 | Center for Clinical Studies, Texas | Feb 2002 | |
| NCT01136525 | Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions | P1 | completed | 41 | Dr. Reddy's Laboratories Limited | Feb 2007 | |
| NCT01136538 | Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition | P1 | completed | 34 | Dr. Reddy's Laboratories Limited | Feb 2007 | |
| NCT00306293 | VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 | P4 | completed | 70 | GlaxoSmithKline | Feb 2006 | |
| NCT01132716 | Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions | N/A | completed | 48 | Roxane Laboratories | Sep 2006 | |
| NCT01132729 | Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions | N/A | completed | 48 | Roxane Laboratories | Sep 2006 | |
| NCT00562770 | Oral Valganciclovir Versus Valacyclovir | P2 | completed | 46 | M.D. Anderson Cancer Center | Sep 2003 | |
| NCT00161434 | A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons | P4 | completed | 60 | University of Washington | Mar 2003 | |
| NCT00274404 | Controlled Trial of Valacyclovir in Infectious Mononucleosis | P1/P2 | completed | 20 | University of Minnesota | Feb 2004 | |
| NCT00650494 | Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg | P1 | completed | 66 | Mylan Pharmaceuticals Inc | Aug 2005 | |
| NCT00158509 | Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding | P2 | completed | 215 | French National Agency for Research on AIDS and Viral Hepatitis | Aug 2004 | |
| NCT00649870 | Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg | P1 | completed | 26 | Mylan Pharmaceuticals Inc | May 2005 | |
| NCT00649974 | Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg | P1 | completed | 28 | Mylan Pharmaceuticals Inc | May 2005 | |
| NCT00042328 | A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients | P2 | completed | 30 | Baylor College of Medicine | Aug 2001 | |
| NCT00059592 | Valacyclovir in Immunocompromised Children | P1 | completed | 37 | Baylor College of Medicine | Apr 1998 | |
| NCT01149499 | Valacyclovir 1000 mg Tablet Under Fasting Conditions | P1 | completed | 60 | Teva Pharmaceuticals USA | Jan 2005 | |
| NCT01686464 | A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy | N/A | completed | 882 | Wenzhou Medical University | Jun 1998 | |
| NCT00045292 | Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation | P3 | completed | 0 | Fred Hutchinson Cancer Center | Apr 2002 | |
| NCT00079911 | A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons | P4 | terminated | 7 | GlaxoSmithKline | Mar 2004 | |
| NCT01149460 | Valacyclovir 1000 mg Tablet Under Fed Conditions | P1 | completed | 36 | Teva Pharmaceuticals USA | Sep 2004 | |
| NCT00378976 | HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men. | P3 | completed | 20 | University of Washington | Aug 2003 | |
| NCT00561106 | PVBP | Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy | N/A | completed | 42 | Universidad de la Republica | Dec 2002 |
| NCT00001038 | A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients | P3 | completed | 1,200 | National Institute of Allergy and Infectious Diseases (NIAID) | — | |
| NCT00002404 | The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients | N/A | completed | 30 | Glaxo Wellcome | — | |
| NCT00002084 | A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients | N/A | completed | 0 | Glaxo Wellcome | — | |
| NCT00002000 | A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients | N/A | completed | 0 | Glaxo Wellcome | — | |
| NCT00001054 | The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children | P1 | withdrawn | 0 | National Institute of Allergy and Infectious Diseases (NIAID) | — | |
| NCT00005663 | A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients | P3 | unknown | 0 | Glaxo Wellcome | Jun 1999 | |
| NCT00006131 | Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster | N/A | completed | 66 | National Center for Research Resources (NCRR) | Jan 1997 |
Valacyclovir clinical trials: frequently asked questions
- How many Valacyclovir clinical trials are there?
- 111 Valacyclovir clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 9 are actively recruiting participants. 80 are marked completed.
- Are Valacyclovir clinical trials recruiting in 2026?
- Yes — 9 Valacyclovir trials are actively recruiting in 2026, with 12 U.S. sites across 10 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Valacyclovir being studied for?
- Valacyclovir is being studied for Herpes Simplex, HIV Infections, Herpes Zoster, Healthy, Genital Herpes and 105 more. The trials are grouped by indication on this page.
- What phase is Valacyclovir in?
- Valacyclovir clinical trials span 17 Phase 4, 13 Phase 3, 32 Phase 2, 25 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Valacyclovir clinical trials?
- The lead sponsor across the most Valacyclovir trials is Candel Therapeutics, Inc., with 61 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Valacycloviras an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: