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    Summary
    EudraCT Number:2017-004160-35
    Sponsor's Protocol Code Number:ISR-003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2017-004160-35
    A.3Full title of the trial
    A prospective, randomised, controlled, parallel arm, open phase IIa study on the efficacy and safety of the GnRH analogue triptorelin for HIV-1 reservoir reduction in HIV-1 infected male adult patients on suppressive ART
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, controlled, parallel arm and open study on the efficacy and safety of triptorelin (a GnRH analogue) for HIV-1 reservoir reduction in HIV-1 infected male adult patients on ART medication
    A.4.1Sponsor's protocol code numberISR-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImmune System Regulation AB (ISR)
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportISR AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScandinavian Development Services (SDS)
    B.5.2Functional name of contact pointAgneta Wennerholm
    B.5.3 Address:
    B.5.3.1Street AddressSvärdvägen 23
    B.5.3.2Town/ cityDanderyd
    B.5.3.3Post code18233
    B.5.3.4CountrySweden
    B.5.4Telephone number46767831118
    B.5.6E-mailagneta.wennerholm@scanddev.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gonapeptyl Depot
    D.2.1.1.2Name of the Marketing Authorisation holderFerring SAU (Spain)
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELIN ACETATE
    D.3.9.1CAS number 140194-24-7
    D.3.9.4EV Substance CodeSUB04985MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV-1 infection
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of 12 weeks of triptorelin depot treatment in ART treated HIV-1 infected male patients (active group) compared to HIV-1 infected male patients on ART only (control group).
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and tolerability of 12 weeks of triptorelin depot treatment in ART treated HIV-1 infected male patients (active group) compared to HIV-1 infected male patients on ART only (control group).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male gender
    2. 18 to 65 years of age, inclusive, at the time of informed consent
    3. Ability and willingness to give a written or orally witnessed informed consent
    4. HIV-1 infection as documented by HIV antibody test
    5. CD4+ cell count >300 cells/µL at screening
    6. Total HIV-1 DNA level between 100 to 5000 copies/million PBMC as measured by real-time PCR within 4 months prior to screening
    7. Plasma HIV-1 RNA level <50 copies/mL for the last year (one blip allowed; blip defined as HIV RNA between 50-150 copies/mL) including a plasma HIV-1 RNA level <50 copies/mL at screening
    8. On triple combination ART (two nucleoside reverse transcriptase inhibitors (NRTI) + one integrase inhibitor or protease inhibitor or one non-NRTI (NNRTI)) for minimum 36 months (assessed at screening)
    9. Currently on continuous triple combination ART as specified above (i.e. no changes in medication) the past 4 months prior to screening
    E.4Principal exclusion criteria
    1. Treatment failure while on triple ART
    2. Nadir CD4+ count < 200 cells/µL
    3. History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
    4. Known positive result of screening for hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive). Patients treated for HCV and assessed as cured by treating physician is eligible for the study
    5. Serious ongoing infection
    6. Abnormal liver biochemical tests > 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP)
    7. Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator
    8. Current treatment with testosterone
    9. History of any clinically significant kidney disease as determined by the Investigator or eGFR < 60 mL/min/1.73 m2 at screening. (Patients on dolutegravir with an eGFR<60 may be verified for study inclusion by analysis of cystatin C that should then be assessed as normal by the Investigator in order for the patient to be eligible)
    10. Diabetes mellitus or a fasting plasma blood glucose >7.0 mmol/L at screening
    11. Intolerance or contraindication to injectable triptorelin
    12. Vital signs, physical examination or lab results that exhibit evidence of acute illness
    13. Known history of moderate or severe depression (see definitions in ICD-10) within the past 5 years
    14. Any congenital or acquired prolongation of the QTc interval and use of any drugs that has been proven to prolong the QTc interval (Normal QTc interval defined as <450 msec)
    15. An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician
    16. Involvement in any other drug study within 30 days prior to this study entry
    17. Any medical condition that in the opinion of the Investigator would compromise the patient’s ability to participate in the study
    18. Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change from baseline to week 12 in the levels of total HIV-1 DNA levels in CD4+ cells in the active group compared to the mean change in the control group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 assessment versus baseline
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are to evaluate the:
    • mean change of the HLA class 1 expression from baseline to week 12 in the active group compared to the mean change in the control group.
    • mean change in the CD4+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.
    • mean change in the CD8+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.

    The following safety parameters will be used to address the safety and tolerability portion of the secondary objectives:
    • adverse events (AEs) and serious adverse events (SAEs), safety laboratory test results, physical examination findings and vital signs results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints: week 12 assessment versus baseline
    Safety endpoints: all timepoints versus baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The exploratory blood samples taken at baseline and week 12 will be used for biomarker research in the field of HIV and/or GnRH related research (see section 10.4.3 in study protocol).
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparator is no treatment (only ART)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 52
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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