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    Summary
    EudraCT Number:2016-005078-37
    Sponsor's Protocol Code Number:SOPHOCLES-P4G
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-29
    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 ConcernedGreece - EOF
    A.2EudraCT number2016-005078-37
    A.3Full title of the trial
    Public health targeting of PrEP at HIV positives’ bridging networks
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to reduce the risk of sexually acquired HIV-1 in adults at high risk.
    A.4.1Sponsor's protocol code numberSOPHOCLES-P4G
    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 SponsorHellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCreative Pharma Services SA
    B.5.2Functional name of contact pointClinical
    B.5.3 Address:
    B.5.3.1Street Address286 Kifisias Ave.
    B.5.3.2Town/ cityHalandri
    B.5.3.3Post code15232
    B.5.3.4CountryGreece
    B.5.4Telephone number+302103259350
    B.5.5Fax number+302103259380
    B.5.6E-maildtsapoga@creativephs.com
    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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameTruvada (emtricitabine and tenofovir disoproxil fumarate)
    D.3.2Product code Truvada(emtricitabine&tenofovirdisoproxil fumarate
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 300
    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
    Healthy volunteers
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10020187
    E.1.2Term HIV test negative
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1)To identify the highest at risk HIV negative populations, that participate in local PWID networks (bridge networks), in which an infected person has been identified, and to administer PrEP to them.

    2)To gather data on the early parameters in the PrEP cascade (HIV virus testing, connection to PrEP care, adherence to care and PrEP uptake, sexual behaviour and compliance with the therapy) in order to utilize this information in simulations and models regarding the effectiveness of PrEP as a public health intervention.

    Safety objective
    To assess the safety and tolerability of Truvada® during the study
    period.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Born to male gender, age 18 years or more.

    2. Documented negative HIV antibody test(s) immediately before starting PrEP medication (up until 3 days before commencement of therapy).

    3. Completed screen for STIs (syphilis, gonorrhoea, chlamydia).

    4. Confirm that the patient is at substantial, ongoing, high risk for acquiring HIV infection in the past 6 months:
    o Patients with sexual (MSM, MSMTF) or intravenous drug use risks for acquiring HIV should be considered for starting the PrEP medication.
    • Sexual risk includes (1) condomless anal sex with ≥2 male or transgender female partners; (2) ≥2 episodes of anal sex with at least 1 HIV-infected partner; or (3) sex with a male or transgender female partner and self-reported history of syphilis, rectal gonorrhoea, or rectal chlamydia.

    5. Confirm that the “patient’s” calculated creatinine clearance is greater than or equal to 60 mL/minute (via Cockcroft-Gault formula).

    6. Willing and able to provide written informed consent.
    E.4Principal exclusion criteria
    1. An acute viral illness that could be due to a primary HIV infection syndrome.

    2. Any contraindications to Truvada® according to the current package insert.

    3. Treatment for hepatitis B infection, ongoing or programmed.

    4. Administration (current or expected) of a treatment that may be toxic to the kidneys (long-term anti-inflammatory use).

    5. Serious disease which could require a treatment that could disrupt the compliance to PrEP.

    6. Participation in other interventional clinical trials 30 days prior to enrolment in the present clinical study.

    7. Inability or unwillingness to comply to study protocol requirement adjunct to primary objectives.
    E.5 End points
    E.5.1Primary end point(s)
    1. Linkage to PrEP care including the first 2 visits within two weeks.
    2. Missed visits proportion (MVP) during the treatment and follow-up periods of the study.
    3. Treatment compliance measured as i) percentage of ingested doses (patient reported outcome, PRO), ii) days covered according to the drug dispensing logs.
    4. Active substance concentration in Drug Blot Specimen (DBS) in months 3, 6, 9 and 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. The first 2 visits within two weeks.
    2. During the treatment and follow-up periods of the study.
    3. Treatment compliance measured as i) percentage of ingested doses (patient reported outcome, PRO), ii) days covered according to the drug dispensing logs.
    4. In months 3, 6, 9 and 12.
    E.5.2Secondary end point(s)
    1. HIV infections acquired between trial entry and 12th month.
    2. Sexually transmitted infections acquired between trial entry and 12th month.
    3. Reported number of stable and casual sex partners as evidenced by participants’ responses to interviewer-administered questionnaires at months 3, 6, 9, and 12.
    4. Number of sexual partners with whom he had unprotected sex between trial entry and 12th month.
    5. Number of acts of anal intercourse protected and unprotected by a condom, between trial entry and 12th month.
    6. Assessment of ASSISTGR questionnaire (baseline and 12th month).
    7. Assessment of BSIGR questionnaire (baseline and 12th month).
    8. Assessment of Stigma Scale for HIV (baseline and 12th month).

    Safety outcome
    1. The incidence of AE and SAE, nature, seriousness, relatedness and severity of AE during Truvada® administration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Between trial entry and 12th month.
    2. Between trial entry and 12th month.
    3. At months 3, 6, 9, and 12.
    4. Between trial entry and 12th month.
    5. Between trial entry and 12th month.
    6. Baseline and 12th month.
    7. Baseline and 12th month.
    8. Baseline and 12th month.

    Safety outcome
    1. During Truvada® administration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state100
    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 Decision2017-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
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