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    Summary
    EudraCT Number:2016-000439-42
    Sponsor's Protocol Code Number:TAP
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-11-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000439-42
    A.3Full title of the trial
    The time to protection and adherence requirements of TRUVADA® and DESCOVY® required for protection from HIV-1 infection: bridging the data gaps
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the time to protection and adherence requirements of TRUVADA® and DESCOVY® antiretroviral medications required for protection from HIV-1 infection:
    A.3.2Name or abbreviated title of the trial where available
    TAP Trial
    A.4.1Sponsor's protocol code numberTAP
    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 SponsorGuy's & St. Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportGilead Sciences Inc
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBritish HIV Association(BHIVA)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuys and St Thomas’ NHS Foundation Trust
    B.5.2Functional name of contact pointDr Julie Fox
    B.5.3 Address:
    B.5.3.1Street AddressHarrison Wing, 2nd Floor Southwark Wing, Guy’s Hospital, Great Maze Pond,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440207188 2643
    B.5.6E-mailJulie.fox@kcl.ac.uk
    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 Descovy 200 / 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameDescovy 200 / 25 mg
    D.3.2Product code J05AR17
    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 CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir alafenamide fumarate
    D.3.9.1CAS number 1392275-56-7
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 200 / 245 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 200 / 245 mg
    D.3.2Product code J05AR03
    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 CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir disoproxil
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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
    Human Immunodeficiency Viruses
    E.1.1.1Medical condition in easily understood language
    HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For each drug (Truvada and Descovy) we have the following objectives:
    Part 1:
    1.To determine the level of drug required in the plasma, saliva, vagina and rectum for ex vivo protection from HIV-1

    Part 2:
    1. To determine the minimal dosing requirement for on demand PreP

    E.2.2Secondary objectives of the trial
    For each drug (Truvada and Descovy) we have the following objectives:
    Part 1:
    1. To determine the time from first dose of drug to ex vivo protection from HIV-1 infection
    2. To determine the time to cessation of ex vivo protection from HIV-1 following stopping ART after attaining steady state.
    3. To determine the impact of TRUVADA® and DESCOVY® on the genital microbiome in men and women
    4. To determine the relationship between protection from ex vivo infection in tissue and Peripheral Blood Mononuclear Cells (PBMC)
    5. To investigate PrEP acceptability and feedback on the trial implementation


    Part 2:
    1. To determine the level of drug required in the plasma, saliva, vagina and rectum for ex vivo protection from HIV-1
    2. To determine the optimal time from PrEP dosing to HIV exposure
    3. To determine the contribution of post exposure dosing in on-demand PrEP
    4. To investigate PrEP acceptability and feedback on the trial implementation


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The ability to understand and sign a written informed consent form prior to participation in any screening procedures and must be willing to comply with all trial requirements.
    2. Male or non-pregnant, non-lactating females
    3. Age between 18 to 60 years, inclusive.
    4. Weight above 35kg.
    5. Negative antibody/antigen combined test for HIV.
    6. Women of childbearing potential (WOCBP)( i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause) who are participating in sexual intercourse that could result in pregnancy, must be using highly effective contraception throughout the study and for two weeks after the study. This includes intrauterine device, , anatomical sterility in self or partner, oral hormonal methods, and implant contraceptives. In case of anatomical sterility in a partner, for example vasectomy, it will be considered a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success
    7. Female participants who consent not use any vaginal products or objects or have vaginal sex for 48 hours before and after the collection of vaginal fluid and vaginal biopsies. This list includes tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method),douches, lubricants, vibrators/dildos, and drying agents.
    8. Males participating in sexual intercourse that could result in pregnancy who consent to use condoms during the duration of the study.
    9. Men and women who consent not to use anal products or objects including but not exclusive to douches, lubricants and vibrators/dildos, butt plugs or urethral sounds or have receptive anal intercourse for 48 hours before and after the collection of rectal biopsies.
    E.4Principal exclusion criteria
    1. Any significant acute or chronic medical illness as determined by the investigator.
    2. Evidence of organ dysfunction or any clinically significant abnormality in physical examination, vital signs or clinical laboratory determinations.
    3. Positive blood screen for syphilis (RPR), hepatitis B (HBsAg) and/or C antibodies.
    4. Positive blood screen for HIV antibodies
    5. Positive screen for sexually transmitted infections at screening visit
    6. High-risk behaviour for HIV infection, which is defined as having one of the following within three months before trial day 0 (first dose):
    i. had condomless vaginal or anal sex with a known HIV-1 infected person who is not receiving ART, or a casual partner.
    ii. engaged in sex work for money or drugs.
    iii. acquired a bacterial sexually transmitted disease.
    7. Females who are pregnant or breast-feeding.
    8. Clinically significant laboratory abnormalities as determined by an investigator.
    9. Participation in a clinical trial of an Investigational product within 1 month of planned baseline enrolment and for the duration of the trial.
    10. Receiving any of the following medications; carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, St. John's wort, ketoconazole, itraconazole, fluconazole, Isavuconazole and ciclosporin.
    11. Hypersensitivity to the IMPs active substances or to any of the excipients
    E.5 End points
    E.5.1Primary end point(s)
    Non-infection of vaginal and rectal tissue with HIV (in the lab) at 15 days following ex vivo challenge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 Regime 1:

    Biopsy on treatment:day 4,7 or 21
    Biopsy off treatment: day 29,31 or 33

    Part 1 Regime 2:

    Biopsy on treatment:day 65,69 or 73
    Biopsy off treatment: day 90,92 or 93

    Part 2
    Biopsy on and off treatment:day 4,7 or 21
    E.5.2Secondary end point(s)
    The mean p24 antigen level area under the curve (AUC) and p24 antigen slope from day 3 to day 15
    b. Drug levels in plasma (TFV, FTC, TAF), peripheral blood mononuclear cells CD4 T cells (TFV-DP and FTC-TP), saliva, vaginal and rectal fluid following PrEP initiation and after cessation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1 Regime 1:

    On treatment:Samples at day 4,7 or 21
    Off treatment: Samples at day 29,31 or 33

    Part 1 Regime 2:

    On treatment: Samples at day 4,7 or 21
    Off treatment: Samples at day 29,30 or 33

    Part 2
    On and off treatment: Samples at day 4,7 or 21
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Data lock. Data lock will be defined as all participant clinical visit data, laboratory data and qualitative data being obtained and cleaned in preparation for transfer to statistician.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-19
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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