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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03073967




Registration number
NCT03073967
Ethics application status
Date submitted
3/03/2017
Date registered
8/03/2017

Titles & IDs
Public title
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
Scientific 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)
Secondary ID [1] 0 0
AIC316-03-II-01
Universal Trial Number (UTN)
Trial acronym
PRIOH-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HSV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Pritelivir
Treatment: Drugs - Investigator's choice

Experimental: Part C, Pritelivir - Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Active comparator: Part C, - 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.

Experimental: Part D, Pritelivir - Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Experimental: Part E, Pritelivir - Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Experimental: Part F, Pritelivir - Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days


Treatment: Drugs: Pritelivir
100 mg oral tablets

Treatment: Drugs: Investigator's choice
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy measured by cure rate
Timepoint [1] 0 0
Up to a maximum of 28 days
Secondary outcome [1] 0 0
Efficacy measured by cure rate
Timepoint [1] 0 0
Up to a maximum of 42 days
Secondary outcome [2] 0 0
Efficacy measured by time to lesion healing
Timepoint [2] 0 0
Up to a maximum of 42 days
Secondary outcome [3] 0 0
Efficacy measured by recurrence rate
Timepoint [3] 0 0
At 2 months following post treatment visit, from randomization up to a maximum of 108 days
Secondary outcome [4] 0 0
Efficacy measured by recurrence rate
Timepoint [4] 0 0
At 3 months following post treatment visit, from randomization up to a maximum of 139 days
Secondary outcome [5] 0 0
Efficacy measured by pain rate
Timepoint [5] 0 0
Up to a maximum of 42 days
Secondary outcome [6] 0 0
Efficacy measured by time to pain cessation at site of lesion
Timepoint [6] 0 0
Up to a maximum of 42 days
Secondary outcome [7] 0 0
Efficacy measured by average pain score
Timepoint [7] 0 0
Up to a maximum of 42 days
Secondary outcome [8] 0 0
Efficacy measured by clinical shedding rate
Timepoint [8] 0 0
From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days
Secondary outcome [9] 0 0
Efficacy measured by time to cessation of shedding
Timepoint [9] 0 0
Up to a maximum of 42 days
Secondary outcome [10] 0 0
Efficacy measured by mean log number of HSV DNA copies
Timepoint [10] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [11] 0 0
Efficacy measured by resistance to trial medication
Timepoint [11] 0 0
From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days
Secondary outcome [12] 0 0
Safety measured by number of subjects developing chronic kidney disease
Timepoint [12] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [13] 0 0
Safety measured by percentage of subjects developing chronic kidney disease
Timepoint [13] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [14] 0 0
Safety measured by percentage of subjects developing acute Kidney Injury
Timepoint [14] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [15] 0 0
Safety measured by percentage of subjects developing renal impairment
Timepoint [15] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [16] 0 0
Safety measured by percentage of subjects developing electrolyte abnormality
Timepoint [16] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [17] 0 0
Safety measured by percentage of subjects developing seizures
Timepoint [17] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [18] 0 0
Safety measured by percentage of subjects developing anemia
Timepoint [18] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [19] 0 0
Safety measured by adverse events
Timepoint [19] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [20] 0 0
Safety measured by haematology
Timepoint [20] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [21] 0 0
Safety measured by lymphadenopathy
Timepoint [21] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [22] 0 0
Safety measured by CRP (C reactive protein )
Timepoint [22] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [23] 0 0
Safety measured by cutaneous adverse events
Timepoint [23] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [24] 0 0
Safety measured by (a)PTT (partial thromboplastin time)
Timepoint [24] 0 0
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
Secondary outcome [25] 0 0
Safety measured by discontinuation rate
Timepoint [25] 0 0
Up to a maximum of 42 days

Eligibility
Key inclusion criteria
Part C inclusion criteria

1. 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.
2. 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.
3. Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy.
4. Willingness to use highly effective birth control.
5. 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.
6. Negative serum ß-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1.
7. 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:

2. 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:

2. Recurrent mucocutaneous HSV infection considered ACV-S.

Part C exclusion criteria

1. Known resistance/intolerance to pritelivir or any of the excipients.
2. Previous treatment in PRIOH-1.
3. Baseline safety laboratory abnormalities.
4. History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir.
5. Hemodialysis for any indication and ESRD (eGFR <15 mL/min; stage 5 CKD)
6. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases.
7. Abnormalities in hematological, clinical chemical or any other laboratory variables.
8. Not able to communicate meaningfully with the Investigator and site staff.
9. Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial.
10. Any other important local condition.
11. Pregnant and/or breastfeeding women.
12. 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:
13. 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:

13. 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
153
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Health - Royal Melbourne Hospital - Parkville
Recruitment hospital [2] 0 0
Westmead Hospital, Centre for Infectious Disease and Microbiology - Westmead
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Córdoba
Country [20] 0 0
Argentina
State/province [20] 0 0
La Plata
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Roeselare
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
France
State/province [24] 0 0
Limoges
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Georgia
State/province [27] 0 0
Tbilisi
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
Country [29] 0 0
Germany
State/province [29] 0 0
Köln
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Heraklion
Country [32] 0 0
Israel
State/province [32] 0 0
Tel-Hashomer
Country [33] 0 0
Italy
State/province [33] 0 0
Calabria
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Pavia
Country [36] 0 0
Mexico
State/province [36] 0 0
Chihuahua
Country [37] 0 0
Mexico
State/province [37] 0 0
Distrito Federal
Country [38] 0 0
Mexico
State/province [38] 0 0
Durango
Country [39] 0 0
Mexico
State/province [39] 0 0
Guadalajara
Country [40] 0 0
Mexico
State/province [40] 0 0
Veracruz
Country [41] 0 0
Switzerland
State/province [41] 0 0
Genève
Country [42] 0 0
Switzerland
State/province [42] 0 0
Zuerich
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AiCuris Anti-infective Cures AG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medpace, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03073967