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    Summary
    EudraCT Number:2021-000016-28
    Sponsor's Protocol Code Number:212483
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-21
    Trial results View 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-000016-28
    A.3Full title of the trial
    A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatment-naïve adults
    Estudo de Fase IIb, randomizado, duplo-cego, de grupos paralelos, para avaliar a eficácia, segurança, tolerabilidade e perfil de resistência de GSK3640254 em combinação com dolutegravir em comparação com dolutegravir mais lamivudina em adultos infetados pelo HIV-1 não submetidos a tratamento anterior
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIb Clinical Trial of GSK3640254 + Dolutegravir (DTG) in HIV-1 Infected Treatment-Naive Adults
    Estudo clínico de Fase IIb de GSK3640254 + dolutegravir (DTG) em adultos infetados pelo HIV-1 não submetidos a tratamento anterior
    A.3.2Name or abbreviated title of the trial where available
    DYNAMIC
    DYNAMIC
    A.4.1Sponsor's protocol code number212483
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04900038
    A.5.4Other Identifiers
    Name:IND NumberNumber:139838
    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 SponsorViiV Healthcare UK Limited
    B.1.3.4CountryUnited Kingdom
    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 supportViiV Healthcare UK (No. 4) Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd.
    B.5.2Functional name of contact pointGSK Clinical Support HelpDesk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440208990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 No
    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 nameGSK3640254
    D.3.4Pharmaceutical form 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 INNNot Available
    D.3.9.1CAS number 1818867-24-1
    D.3.9.2Current sponsor codeGSK3640254
    D.3.9.3Other descriptive nameGSK3640254D where D denotes the methanesulfonate salt
    D.3.9.4EV Substance CodeSUB218087
    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 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 No
    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 nameGSK3640254
    D.3.4Pharmaceutical form 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 INNNot Available
    D.3.9.1CAS number 1818867-24-1
    D.3.9.2Current sponsor codeGSK3640254
    D.3.9.3Other descriptive nameGSK3640254D where D denotes the methanesulfonate salt
    D.3.9.4EV Substance CodeSUB218087
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 Tivicay
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare BV
    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 nameTivicay 50 mg film-coated tablets
    D.3.2Product code Not Applicable
    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 INNDolutegravir
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameDOLUTEGRAVIR
    D.3.9.4EV Substance CodeSUB35122
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 4
    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 Epivir
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare BV
    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 nameOver-encapsulated Epivir® (Lamivudine) Tablets
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form Capsule
    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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameLamivudine
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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: 5
    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 Epivir
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare BV
    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 nameEpivir 300 mg film-coated tablets
    D.3.2Product code Not Applicable
    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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameLamivudine
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Human Immunodeficiency Virus Type-1 (HIV-1)
    Vírus da imunodeficiência humana Tipo-1 (VIH-1)
    E.1.1.1Medical condition in easily understood language
    HIV infection
    Infeção por VIH-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate antiviral efficacy of GSK3640254 + DTG, relative to DTG + 3TC at Week 24 in HIV-1 infected, ART-naïve participants
    Avaliar a eficácia antiviral de GSK3640254 + DTG em comparação com DTG + 3TC na Semana 24 em participantes infetados pelo HIV-1 não submetidos a TAR anterior
    E.2.2Secondary objectives of the trial
    • To evaluate the antiviral activity of GSK3640254 + DTG relative to DTG + 3TC at Week 48;
    • To evaluate safety and tolerability of GSK3640254 when given in combination with DTG, relative to DTG + 3TC;
    • To assess the development of viral resistance to GSK3640254 and other on-study ART in participants experiencing virologic failure through Week 48;
    • To assess the steady-state exposure of GSK3640254 when given in combination with DTG.
    - Avaliar a atividade antiviral de GSK3640254 + DTG em comparação com DTG + 3TC na Semana 48;
    - Avaliar a segurança e a tolerabilidade do GSK3640254 quando administrado em combinação com DTG, em comparação com DTG + 3TC;
    - Avaliar o desenvolvimento de resistência viral ao GSK3640254 e outras TAR no estudo em participantes que revelem falência virológica até à Semana 48.
    - Avaliar a exposição no estado de equilíbrio ao GSK3640254 quando administrado em combinação com DTG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age:
    1. Participants must be 18 years of age inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics:
    2. Treatment-naïve, defined as no ARVs (in combination or monotherapy) received after a known diagnosis of HIV-1 infection;
    NOTE: Use of PrEP (prior to known HIV-1 infection) is allowed and still meets inclusion. PrEP is used by individuals who are not infected with HIV-1 but who are at high risk for acquiring the virus. PrEP alone is not sufficient to treat HIV and the use of PrEP is stopped if/when a diagnosis of HIV is made.
    3. Documented HIV infection and Screening plasma HIV-1 RNA ≥1000 c/mL;
    4. Screening CD4+ T-cell count ≥250 cells/mm3;
    Weight:
    5. Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and body mass index (BMI) > 18.5 kg/m2. Calculations will utilize sex assigned at birth;
    Sex:
    Sex and Contraceptive/Barrier Requirements:
    6. Male and female
    a. Participants who are male at birth: There are no contraceptive requirements for participants who are male at birth
    b. Participants who are female at birth:
    Contraceptive use by participants who are female at birth should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • A participant who is female at birth is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
    o Is not a participant of childbearing potential (PONCBP) as defined in Section 10.4.
    OR
    o Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Section 10.4 during the study intervention period and until after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
    o If a hormonal method is selected, the participant is required to be clinically stable on it for at least one month prior to starting treatment in the study.
    • A POCBP must have a negative highly sensitive serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 before starting study intervention .
    o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    • Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.5 Pregnancy Testing.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy Informed Consent:
    7. Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Other:
    8. For participants enrolled in France: a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    Idade:
    1. Os participantes devem têr 18 anos de idade inclusive, no momento da assinatura do Formulario do Consentimento Esclarecido.
    Tipo de participante e características da doença:
    2. Não submetidos a TAR anterior, definido como nenhum ARV (em combinação ou monoterapia) recebido após um diagnóstico conhecido de infecção por HIV-1;
    NOTA: O uso de PrEP (antes da infecção por HIV-1 conhecida) é permitido e ainda atende à inclusão. A PrEP é usada por indivíduos que não estão infectados com o HIV-1, mas que apresentam alto risco de adquirir o vírus. A PrEP por si só não é suficiente para tratar o HIV e o uso da PrEP é interrompido se / quando um diagnóstico de HIV é feito.
    3. Infecção de HIV documentada e triagem de RNA de HIV-1 plasmático ≥1000 c / mL
    4. Contagem de células T CD4 + ≥250 células / mm3 na Seleção;
    Peso
    5. Peso corporal ≥50,0 kg para homens e ≥45,0 kg (99 lbs) para mulheres e índice de massa corporal (IMC)> 18,5 kg / m2. Os cálculos usarão o sexo atribuído no nascimento;
    Sexo
    Sexo e requisitos de anticoncepcionais / barreiras:
    6. Masculino e feminino
    a. Participantes do sexo masculino ao nascer: Não há requisitos contraceptivos para participantes do sexo masculino ao nascer
    b. Participantes que nasceram do sexo feminino:
    O uso de anticoncepcionais por participantes do sexo feminino ao nascer deve ser consistente com os regulamentos locais em relação aos métodos de contracepção para aqueles que participam de estudos clínicos.
    • Uma participante que é mulher ao nascer é elegível para participar se não estiver grávida ou amamentando, e uma das seguintes condições se aplica:
    - Se não é participante com potencial para engravidar (PONCBP) as defined in Section 10.4.
    o
    - É um POCBP e usa um método anticoncepcional altamente eficaz (com uma taxa de falha de <1% ao ano), com baixa dependência do usuário, conforme descrito na Seção 10.4 durante o período de intervenção do estudo e até após a última dose da intervenção do estudo. O investigador deve avaliar o potencial de falha do método anticoncepcional (por exemplo, abandono, iniciado recentemente) em relação à primeira dose da intervenção do estudo.
    - Se um método hormonal for selecionado, o participante deve estar clinicamente estável por pelo menos um mês antes de iniciar o tratamento no estudo.
    - Uma POCBP deve ter um teste de gravidez de soro altamente sensível negativo na triagem e um teste de gravidez de urina negativo no Dia 1 antes de iniciar a intervenção do estudo.
    - Se um teste de urina não puder ser confirmado como negativo (por exemplo, um resultado ambíguo), um teste de gravidez de soro é necessário. Nesses casos, a participante deve ser excluída da participação se o resultado sérico da gravidez for positivo.
    - Os requisitos adicionais para teste de gravidez durante e após a intervenção do estudo estão localizados na Seção 8.2.5 Teste de gravidez.
    - O investigador é responsável pela revisão do histórico médico, histórico menstrual e atividade sexual recente para diminuir o risco de inclusão de uma participante com gravidez precoce não detectada. Consentimento informado:
    7. Capaz de dar consentimento informado assinado conforme descrito na Seção 10.1, que inclui conformidade com os requisitos e restrições listados no formulário de consentimento informado (CIF) e neste protocolo.
    Outro:
    8. Para participantes inscritos na França: um participante será elegível para inclusão neste estudo somente se for afiliado ou beneficiário de uma categoria de seguridade social.
    E.4Principal exclusion criteria
    1. Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi’s sarcoma not requiring systemic therapy;
    2. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia;
    3. Presence of primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion;
    4. Known history of liver cirrhosis with or without viral hepatitis co-infection;
    5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
    6. History of ongoing or clinically relevant hepatitis within the previous 6 months;
    7. History of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation;
    8. Any history of significant underlying psychiatric disorder, in the opinion of the Investigator or Medical Monitor, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder; or a clinical assessment of suicidality based on the responses on the eC-SSRS.
    9. Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment;
    10. Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the Investigator or Medical Monitor (with or without psychiatric evaluation), could interfere with the participant’s ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant;
    11. A pre-existing condition, in the opinion of the Investigator or Medical Monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory bowel disease), hepatic and/or renal function, or with the absorption, metabolism, and/or excretion of the study interventions or render the participant unable to take oral study treatment;
    12. Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months;
    13. Familial or personal history of long QT syndrome or sudden cardiac death;
    14. Medical history, current or historical, of significant cardiac arrhythmias or ECG findings which, in the opinion of the Investigator or Medical Monitor, will interfere with the safety of the participant;
    15. Active treatment for a viral infection other than HIV-1, such as Hepatitis B, with an agent that is active against HIV-1 (were known to be infected with HIV-1 after treatment for Hepatitis B was completed);
    16. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
    17. Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant;
    18. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication;
    19. Participants who require concomitant medications known to be associated with a prolonged QTc.
    20. Exposure to an experimental drug, human blood product, monoclonal antibody, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment;
    21. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
    22. Historical evidence of the presence of resistance-associated mutations gag A364V or A364A/V. Historical evidence of the presence of resistance to the integrase inhibitor class or to lamivudine.
    23. Creatinine Clearance <50 mL/min;
    24. ALT ≥ 3x ULN or ALT ≥ 2x ULN and total bilirubin ≥ 1.5x ULN (upper limit of normal);
    25. Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and reflex HBV DNA;

    For full list of exclusion criteria, please refer to the protocol.
    1. Qualquer evidência dos Centros de Controle e Prevenção de Doenças (CDC) de doença de Estágio 3 [CDC, 2014], exceto sarcoma de Kaposi cutâneo que não requer terapia sistêmica;
    2. Malignidade em curso diferente de sarcoma de Kaposi cutâneo, carcinoma basocelular ou ressecado, carcinoma cutâneo escamoso não invasivo ou neoplasia intraepitelial cervical, anal ou peniana;
    3. Presença de infecção primária por HIV, evidenciada por síndrome retroviral aguda (por exemplo, febre, mal-estar, fadiga, etc) e / ou evidência de viremia documentada recente (dentro de 3 meses) sem produção de anticorpos e / ou evidência de recente (dentro de 3 meses) ) soroconversão documentada;
    4. História conhecida de cirrose hepática com ou sem coinfecção por hepatite viral;
    5. Doença hepática instável (conforme definido por qualquer um dos seguintes: presença de ascite, encefalopatia, coagulopatia, hipoalbuminemia, varizes esofágicas ou gástricas ou icterícia ou cirrose persistente), anormalidades biliares conhecidas (com exceção da síndrome de Gilbert ou cálculos biliares assintomáticos ou caso contrário, doença hepática crônica estável por avaliação do investigador).
    6. História de hepatite em curso ou clinicamente relevante nos 6 meses anteriores;
    7. História de alergia a medicamentos ou outra que, na opinião do investigador ou do Monitor Médico, contra-indique sua participação;
    8. Qualquer história de transtorno psiquiátrico subjacente significativo, na opinião do Investigador ou Monitor Médico, incluindo, mas não se limitando a esquizofrenia, transtorno bipolar com ou sem sintomas psicóticos, outros transtornos psicóticos ou transtorno esquizotípico (personalidade); ou uma avaliação clínica de suicídio com base nas respostas no eC-SSRS.
    9. Qualquer história de transtorno depressivo maior com ou sem características suicidas, ou transtornos de ansiedade, que exigisse intervenção médica (farmacológica ou não), como hospitalização ou outro tratamento hospitalar e / ou tratamento ambulatorial crônico (> 6 meses);
    10. Qualquer condição física ou psiquiátrica preexistente (incluindo abuso de álcool ou drogas), que, na opinião do Investigador ou Monitor Médico (com ou sem avaliação psiquiátrica), pode interferir na capacidade do participante de cumprir o esquema de dosagem e avaliações de protocolos ou que possam comprometer a segurança do participante;
    11. Uma condição pré-existente, na opinião do investigador ou monitor médico, que pode interferir na anatomia ou motilidade gastrointestinal normal (por exemplo, doença do refluxo gastroesofágico [DRGE], úlceras gástricas, gastrite, doença inflamatória intestinal), hepática e / ou função renal, ou com a absorção, metabolismo e / ou excreção das intervenções do estudo ou impossibilitar o participante de fazer o tratamento oral do estudo;
    12. Infarto do miocárdio, síndrome coronariana aguda, angina instável, acidente vascular cerebral, ataque isquêmico transitório ou claudicação intermitente nos últimos 3 meses;
    13. História familiar ou pessoal de síndrome do QT longo ou morte cardíaca súbita;
    14. História médica, atual ou histórica, de arritmias cardíacas significativas ou achados de ECG que, na opinião do Investigador ou Monitor Médico, irão interferir na segurança do participante;
    15. Tratamento ativo para uma infecção viral diferente de HIV-1, como Hepatite B, com um agente que é ativo contra HIV-1 (eram conhecidos por estarem infectados com HIV-1 depois que o tratamento para Hepatite B foi concluído);
    16. Tratamento com uma vacina imunoterapêutica contra o HIV-1 dentro de 90 dias da triagem;
    17. Tratamento com qualquer um dos seguintes agentes no prazo de 28 dias após a triagem: radioterapia, agentes quimioterápicos citotóxicos, qualquer supressor imunológico sistêmico;
    18. Participantes que recebem qualquer medicamento proibido pelo protocolo e que não desejam ou não podem mudar para um medicamento alternativo;
    19. Participantes que requerem medicamentos concomitantes sabidamente associados a um QTc prolongado.
    20. Exposição a um medicamento experimental, produto de sangue humano, anticorpo monoclonal ou vacina (que não tenha autorização) dentro de 28 dias antes da primeira dose do tratamento do estudo;
    21. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
    22. Evidência de mutações associadas à resistência gag A364V ou A364A / V. Evidência de resistência à classe de inibidores da integração ou lamivudina.
    23. Depuração de creatinina <50 mL/min;
    24. ALT ≥ 3x ULN or ALT ≥ 2x ULN and total bilirubin ≥ 1.5x ULN (upper limit of normal);
    25. Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and reflex HBV DNA;
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 24 using the FDA snapshot algorithm
    Proporção de participantes com RNA de HIV-1 plasmático <50 c / mL na semana 24 usando o algoritmo instantâneo da FD
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    • Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using the FDA snapshot algorithm;
    • Absolute values and changes from baseline in HIV-1 RNA through Weeks 24 and 48;
    • Absolute values and changes from baseline in CD4+ T-cell counts through Weeks 24 and 48;
    • Frequency of SAEs, Deaths and AEs leading to Discontinuation through Weeks 24 and 48;
    • AEs of special interest (AESIs) through Weeks 24 and 48;
    • Changes in genotypic and/or phenotypic profiles of virus compared to baseline;
    • The steady-state plasma PK parameters of GSK3640254 will be assessed based on Sparse PK sampling through Week 48

    • Proporção de participantes com RNA de HIV-1 plasmático <50 c / mL na semana 48 usando o algoritmo instantâneo da FDA;
    • Valores absolutos e alterações da linha de base no RNA do HIV-1 até as Semanas 24 e 48;
    • Valores absolutos e alterações da linha de base na contagem de células T CD4 + até as Semanas 24 e 48;
    • Frequência de SAEs, Mortes e AEs que levam à Descontinuação nas Semanas 24 e 48;
    • AEs de interesse especial (AESIs) até as Semanas 24 e 48;
    • Mudanças nos perfis genotípicos e / ou fenotípicos do vírus em comparação com a linha de base;
    • Os parâmetros de farmacocinética do plasma em estado estacionário de GSK3640254 serão avaliados com base na amostragem de farmacocinética esparsa até a semana 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the time period specified in E.5.2 Secondary end point section.
    Consulte o período de tempo especificado na seção E.5.2 Desfechos secundários.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Resistance profile, Viral Genotyping and Phenotyping Analyses
    Tolerabilidade, perfil de resistência, genotipagem viral e análises de fenotipagem
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Puerto Rico
    Russian Federation
    South Africa
    United States
    France
    Germany
    Italy
    Poland
    Portugal
    Spain
    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
    The end of the study is defined as the date of the last visit of the last participant in the study.
    A participant is considered to have completed the study if the participant has completed all phases of the study including the last visit.
    O final do estudo é definido como a data da última visita do último participante do estudo.
    Um participante é considerado como tendo concluído o estudo se tiver concluído todas as fases do estudo, incluindo a última visita.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 80
    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)
    To provide continued access to an unapproved investigational drug to participants deriving additional therapeutic benefit not expected from locally available standard of care, participants that received GSK3640254 + DTG and who have successfully completed 52 weeks of treatment will be given the opportunity to continue to receive GSK3640254 + DTG as per conditions specified in the protocol until GSK3640254 + DTG is commercially available.
    Para fornecer acesso contínuo a um medicamento experimental não aprovado aos participantes que derivam benefícios terapêuticos adicionais não esperados do padrão de tratamento disponível localmente, os participantes que receberam GSK3640254 + DTG e que completaram 52 semanas de tratamento com sucesso terão a oportunidade de continuar a receber GSK3640254 + DTG de acordo com as condições especificadas no protocolo até GSK3640254 + DTG estar comercialmente disponível.
    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 Decision2021-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-11
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