HSV InfectionPhase 3PRIOH-1NCT03073967
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
A Phase 3 study testing Pritelivir and Investigator's choice in people with HSV Infection, run by AiCuris Anti-infective Cures AG at 70 sites in 15 countries.
Trial summary
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HSV Infection
- What is being tested?
- Pritelivir and Investigator's choice
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 70 sitesin 15 countries
- Study dates
- 8 May 2017to 11 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Part C inclusion criteria
- Immunocompromised men and women of any ethnic group aged ≥16 years. In Canada, Germany, Belgium: Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppressive treatment) men and women of any ethnic group aged >18 years.
- ACV-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic ACV resistance testing for current lesion. Clinical failure is defined as no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high oral doses of acyclovir, valacyclovir or famciclovir.
- Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy.
- Willingness to use highly effective birth control.
- Subject, and/or their legally authorized representative, (proxy consent is not permitted in Germany), must be willing and able to understand the Informed Consent Form.
- Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1.
- Written informed consent. For subjects, who are unable to provide informed consent for whatever reason, written consent must be obtained from the legal representative, (proxy consent is not permitted in Germany).
Part D and F inclusion criteria
All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by:
- ACV-R and foscarnet-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic resistance testing for current lesion or documented intolerance to iv foscarnet requiring cessation of foscarnet treatment or precluding foscarnet treatment.
Subjects will be able to enter Part F only after closure of enrollment in Part D.
Part E inclusion (Part E is not being conducted in Germany)
All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by:
- Recurrent mucocutaneous HSV infection considered ACV-S.
Part C exclusion criteria
- Known resistance/intolerance to pritelivir or any of the excipients.
- Previous treatment in PRIOH-1.
- Baseline safety laboratory abnormalities.
- History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir.
- Hemodialysis for any indication and ESRD (eGFR <15 mL/min; stage 5 CKD)
- History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases.
- Abnormalities in hematological, clinical chemical or any other laboratory variables.
- Not able to communicate meaningfully with the Investigator and site staff.
- Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial.
- Any other important local condition.
- Pregnant and/or breastfeeding women.
- Having received an investigational drug in an investigational drug trial unter certain conditions. Part D (complete) exclusion criteria All exclusion criteria as for Part C, except criterion 12, which is replaced by:
- Having received an investigational drug in an investigational trial within 7 half-lives after the last administration of this drug before initiating trial medication, except for subjects entering Part D, who have previously received foscarnet treatment in Part C of this trial.
Participation in a clinical trial without receiving other investigational drugs (eg, follow-up phase of a trial, observational study) is permitted.
Part E exclusion criteria (Part E is not being conducted in Germany)
All exclusion criteria in Part E are identical to those in Part C with the addition of:
- Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.
Part F exclusion criteria All exclusion criteria for Part D plus 13. Part D open for enrollment
Trial locations and contacts
70 sites in 15 countries.
70 sites in 15 countries
United States33 sites
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
LSU Health Baton Rouge Pulmonary Clinic
Baton Rouge, Louisiana, 70809
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kings Country Hospital Center
Brooklyn, New York, 11203
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, 60527
Department of Medicine J. H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Metro Infectious Disease Consultants - Atlanta
Decatur, Georgia, 30033
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
City of Hope
Duarte, California, 91010
Duke University Medical Center - Division of Infectious Diseases
Durham, North Carolina, 27710
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, 34982
University of Florida (UF) - Division of Infectious Disease
Gainesville, Florida, 32610
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Metro Infectious Disease Consultants, LLC - Huntsville
Huntsville, Alabama, 35801
Lee's Summit MO United States 64086
Lee's Summit, Missouri, 64086
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Links Clinical Trials
Miami, Florida, 33176
University of Minnesota
Minneapolis, Minnesota, 55455
University of South Alabama
Mobile, Alabama, 36604
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Tulane University - School of Medicine
New Orleans, Louisiana, 70112
David H. Koch Center at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of California, Division of Infectious Diseases
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
University of South Florida
Tampa, Florida, 33606
University Arizona - Department of Medicine Arizona Health Sciences Center
Tucson, Arizona, 85724
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
France5 sites
CHU Limoges - Centre national de reference des Herpes virus
Limoges, 87042
CHU de Nantes
Nantes, 44093
Hôpital Saint Louis - AP-HP
Paris, 75010
AP-HP Hopital Necker-Enfants Malades
Paris, 75015
AP-HP Hopital Bichat - Claude Bernard
Paris, 75018
Mexico5 sites
Unidad de Investigacion CIMA SC
Chihuahua City, 64718
Centro de Investigacion Clinica GRAMEL S.C.
Distrito Federal, 03720
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000
Centro de Investigacion Farmaceutica Especializado de Occidente S.C.
Guadalajara, 44160
Arke SMO S.A. de C.V.
Veracruz, 91910
Argentina3 sites
Hospital Rawson
Córdoba, 5000
Sanatorio Mayo Privado S.A.
Córdoba, 5000
Instituto FIDES
La Plata, CP 1900
Belgium3 sites
AZ Sint-Jan Brugge
Bruges, 8000
Centre Hospitalier Universitaire Saint Pierre
Brussels, B1000
AZ Delta
Roeselare, 8800
Germany3 sites
Universitätsklinikum Köln
Cologne, 50937
Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Würzburg
Würzburg, 97080
Italy3 sites
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Calabria, 89133
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Switzerland3 sites
Universitaetsspital Basel
Basel, 4031
Hopitaux universitaires de Geneve
Geneva, 1205
Universitaetsspital Zuerich
Zurich, 8091
United Kingdom3 sites
Nhs Lothian
Edinburgh, EH4 2XU
Research Department of Haematology, UCL Cancer Institute
London, WC1E 6BT
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Australia2 sites
Melbourne Health - Royal Melbourne Hospital
Parkville, 3050
Westmead Hospital, Centre for Infectious Disease and Microbiology
Westmead, 2145
Georgia2 sites
LLC Diakor
Tbilisi, 0159
Multiprofile Clinic Consilium Medulla LTD
Tbilisi, 0186
Greece2 sites
General Hospital of Athens - Laiko
Athens, 11527
Regional University General Hospital of Heraklion
Heraklion, 71110
Canada1 site
Alberta Health Services Cross Cancer Institute at the University of Alberta
Edmonton, Alberta, T6G 1Z2
About this study
Official title: A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).
Read the detailed description
The trial comprises 5 Parts, Part A, B, C, D, E and F.
Part A and Part B (Phase 2) have been finalised.
- Part A is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety in subjects with ACV-resistant mucocutaneous HSV infection, treated with oral pritelivir or intravenous foscarnet.
- Part B is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-resistant-mucocutaneous HSV and who either:
- present with foscarnet-resistance/intolerance, or
- developed foscarnet resistance/intolerance during treatment in Part A (no improvement after at least 5 days of foscarnet therapy or intolerance to foscarnet requiring cessation of foscarnet treatment). Parts C, D, E and F (Phase 3).
- Part C is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety of oral pritelivir in subjects with acyclovir resistent (ACV-R) mucocutaneous HSV episodes. Subjects with ACV-R mucocutaneous HSV infection will be randomized 1:1 to receive either oral pritelivir or Investigator's Choice.
This trial part is designed to show superiority of pritelivir against Investigator's Choice in obtaining clinical cure, ie, number of subjects with all lesions healed within 28 days.
- Part D is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment). Part D has been closed in June 2022.
- Part E is an open-label, multi-center design to assess the safety and efficacy of pritelivir in subjects with acyclovir susceptible (ACV-S) mucocutaneous HSV episodes, (Part E is not being conducted in Germany).
- Part F is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).
- cannot be enrolled into Part D anymore because enrollment into Part D has been completed.
Dosing of trial medication:
Pritelivir oral tablet as single daily doses of 100 mg (following a loading dose of 400 mg as first dose)
Comparator per investigator's choice (provided the drug listed below is nationally approved):
Foscarnet intermittent infusions of 40 mg/kg every 8 hours or 60 mg/kg every 12 hours (to be adjusted in case of renal impairment) for a minimum of 1 hour duration, or Cidofovir iv infusion of 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical treatment, applied 2 to 4 times daily, or Imiquimod 5% topical treatment, 3 times per week.
Duration of treatment:
Until all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier.
A prolongation up to a maximum of 42 days may be possible depending on the clinical progress.
- Conditions
- HSV Infection
- Being tested
- Pritelivir, Investigator's choice
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PritelivirDrug
100 mg oral tablets
Investigator's choiceDrug
Also called Foscarnet or Cidofovir or Imiquimod
Foscarnet iv, 40 mg/kg BW tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg BW given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, Solution for iv infusion or topical application
| Study group | Role | What they receive |
|---|---|---|
| Part C, Pritelivir | Experimental | Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days Receives: Drug: Pritelivir |
| Part C, | Active comparator | Investigator's Choice:
Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days. Receives: Drug: Investigator's choice |
| Part D+F, Pritelivir | Experimental | Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days Receives: Drug: Pritelivir |
| Part E, Pritelivir | Experimental | Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days Receives: Drug: Pritelivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by cure rate
Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.
Measured: Up to a maximum of 28 days
Secondary outcomes (25)
Efficacy measured by cure rate
Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 42 days relative to the total number of subjects treated with trial medication in the respective treatment group.
Measured: Up to a maximum of 42 days
Efficacy measured by time to lesion healing
Time to lesion healing, defined as complete epithelization of the mucocutaneous HSV lesion(s) within the treatment period and no appearance of new lesions, as assessed by the Investigator.
Measured: Up to a maximum of 42 days
Efficacy measured by recurrence rate
Recurrence rate at 2 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.
Measured: At 2 months following post treatment visit, from randomization up to a maximum of 108 days
Efficacy measured by recurrence rate
Recurrence rate at 3 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.
Measured: At 3 months following post treatment visit, from randomization up to a maximum of 139 days
Efficacy measured by pain rate
Number of days with pain at lesion site relative to the total number of days with analyzable pain data through daily subject self-reporting
Measured: Up to a maximum of 42 days
Efficacy measured by time to pain cessation at site of lesion
Starting at first dose of trial medication until pain is no longer reported by the subject (date and time)
Measured: Up to a maximum of 42 days
Efficacy measured by average pain score
Using a single-dimensional scale assessing pain intensity through daily subject self-reporting
Measured: Up to a maximum of 42 days
Efficacy measured by clinical shedding rate
Number of HSV positive swabs per subject relative to the total number of swabs collected per subject from lesion swabs taken from HSV lesion(s)
Measured: From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days
Efficacy measured by time to cessation of shedding
Number of days until swabs taken are negative
Measured: Up to a maximum of 42 days
Efficacy measured by mean log number of HSV DNA copies
Mean log number of HSV DNA copies on HSV DNA positive swabs from lesion(s) as detected by quantitative real-time PCR (polymerase chain reaction).
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Efficacy measured by resistance to trial medication
Resistance to trial medication for lesions not healed within the treatment period or newly appeared lesions under treatment before or at the PoTV.
Measured: From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days
Safety measured by number of subjects developing chronic kidney disease
Chronic kidney disease
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing chronic kidney disease
Chronic kidney disease
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing acute Kidney Injury
Acute Kidney Injury (AKI) stage >1 of KDIGO (Kidney Disease: Improving Global Outcome) criteria (increase in serum creatinine by 2.0 to 2.9 times compared to baseline or urine output <0.5 mL/kg/h for >12 hours)
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing renal impairment
Renal impairment
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing electrolyte abnormality
All abnormal values
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing seizures
All seizures
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing anemia
Haemoglobin measurement
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by adverse events
Incidence of Adverse Events
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by haematology
Incidence of abnormal hematologic laboratory test results
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by lymphadenopathy
Incidence of lymphadenopathy measured by physical examination
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by CRP (C reactive protein )
Incidence of CRP increase
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by cutaneous adverse events
Incidence of cutaneous adverse events by physical examination
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by (a)PTT (partial thromboplastin time)
Incidence of (a)PTT increase
Measured: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by discontinuation rate
Number of subjects discontinuing pritelivir or 'Inverstigator's Choice' due to AE(s) or intolerance relative to the total number of subjects treated with pritelivir or foscarnet, respectively
Measured: Up to a maximum of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start8 May 2017
- Primary completion15 Aug 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCuris Anti-infective Cures AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073967
- Sponsor's protocol ID
- AIC316-03-II-01
- Acronym
- PRIOH-1
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2017
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
- ClinicalTrials.gov ID
- NCT03073967
- Acronym / sponsor ID
- PRIOH-1 / AIC316-03-II-01
- Conditions
- HSV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 8 May 2017 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).
Detailed description
The trial comprises 5 Parts, Part A, B, C, D, E and F.
Part A and Part B (Phase 2) have been finalised.
- Part A is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety in subjects with ACV-resistant mucocutaneous HSV infection, treated with oral pritelivir or intravenous foscarnet.
- Part B is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-resistant-mucocutaneous HSV and who either:
- present with foscarnet-resistance/intolerance, or
- developed foscarnet resistance/intolerance during treatment in Part A (no improvement after at least 5 days of foscarnet therapy or intolerance to foscarnet requiring cessation of foscarnet treatment). Parts C, D, E and F (Phase 3).
- Part C is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety of oral pritelivir in subjects with acyclovir resistent (ACV-R) mucocutaneous HSV episodes. Subjects with ACV-R mucocutaneous HSV infection will be randomized 1:1 to receive either oral pritelivir or Investigator's Choice.
This trial part is designed to show superiority of pritelivir against Investigator's Choice in obtaining clinical cure, ie, number of subjects with all lesions healed within 28 days.
- Part D is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment). Part D has been closed in June 2022.
- Part E is an open-label, multi-center design to assess the safety and efficacy of pritelivir in subjects with acyclovir susceptible (ACV-S) mucocutaneous HSV episodes, (Part E is not being conducted in Germany).
- Part F is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).
- cannot be enrolled into Part D anymore because enrollment into Part D has been completed.
Dosing of trial medication:
Pritelivir oral tablet as single daily doses of 100 mg (following a loading dose of 400 mg as first dose)
Comparator per investigator's choice (provided the drug listed below is nationally approved):
Foscarnet intermittent infusions of 40 mg/kg every 8 hours or 60 mg/kg every 12 hours (to be adjusted in case of renal impairment) for a minimum of 1 hour duration, or Cidofovir iv infusion of 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical treatment, applied 2 to 4 times daily, or Imiquimod 5% topical treatment, 3 times per week.
Duration of treatment:
Until all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier.
A prolongation up to a maximum of 42 days may be possible depending on the clinical progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part C, Pritelivir | Experimental | Drug: PritelivirOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days |
| Part C, | Active comparator | Drug: Investigator's choiceInvestigator's Choice: Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days. |
| Part D+F, Pritelivir | Experimental | Drug: PritelivirOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days |
| Part E, Pritelivir | Experimental | Drug: PritelivirOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pritelivir100 mg oral tablets | Drug | Part C, Pritelivir, Part D+F, Pritelivir, Part E, Pritelivir |
| Investigator's choiceAlso: Foscarnet or Cidofovir or ImiquimodFoscarnet iv, 40 mg/kg BW tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg BW given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, Solution for iv infusion or topical application | Drug | Part C, |
Primary outcome
Efficacy measured by cure rate
Time frame: Up to a maximum of 28 days
Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.
25 secondary outcomes
Efficacy measured by cure rate
Time frame: Up to a maximum of 42 days
Efficacy measured by time to lesion healing
Time frame: Up to a maximum of 42 days
Efficacy measured by recurrence rate
Time frame: At 2 months following post treatment visit, from randomization up to a maximum of 108 days
Efficacy measured by recurrence rate
Time frame: At 3 months following post treatment visit, from randomization up to a maximum of 139 days
Efficacy measured by pain rate
Time frame: Up to a maximum of 42 days
Efficacy measured by time to pain cessation at site of lesion
Time frame: Up to a maximum of 42 days
Efficacy measured by average pain score
Time frame: Up to a maximum of 42 days
Efficacy measured by clinical shedding rate
Time frame: From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days
Efficacy measured by time to cessation of shedding
Time frame: Up to a maximum of 42 days
Efficacy measured by mean log number of HSV DNA copies
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Efficacy measured by resistance to trial medication
Time frame: From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days
Safety measured by number of subjects developing chronic kidney disease
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing chronic kidney disease
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing acute Kidney Injury
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing renal impairment
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing electrolyte abnormality
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing seizures
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by percentage of subjects developing anemia
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by adverse events
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by haematology
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by lymphadenopathy
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by CRP (C reactive protein )
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by cutaneous adverse events
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by (a)PTT (partial thromboplastin time)
Time frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Safety measured by discontinuation rate
Time frame: Up to a maximum of 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
70 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pritelivir and Investigator's choice in people with HSV Infection, run by AiCuris Anti-infective Cures AG at 70 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, France, Mexico, Argentina, Belgium and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy measured by cure rate (time frame: Up to a maximum of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.