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Estudo para comparar Bictegravir/Lenacapavir com a terapia atual em pessoas com HIV-1 tratadas com sucesso com Biktarvy (ARTISTRY-2)

15 de outubro de 2026 atualizado por: Gilead Sciences

Estudo multicêntrico duplo-cego randomizado de fase 3 com controle ativo para avaliar a segurança e eficácia de Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabina/Tenofovir Alafenamida) em pessoas com supressão virológica com HIV-1

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH) who are successfully treated with B/F/TAF (virologically suppressed).

The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) FDC tablets versus continuing on B/F/TAF (50/200/25 mg) FDC tablets in virologically suppressed PWH.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

577

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Aachen, Alemanha, 52062
        • Praxis Dr. Knechten
      • Berlin, Alemanha, 10117
        • Novopraxis Berlin
      • Cologne, Alemanha, 50668
        • Praxis am Ebertplatz
      • Frankfurt, Alemanha, 60590
        • Universitätsklinikum Frankfurt
      • Hamburg, Alemanha, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Munich, Alemanha, 80336
        • LMU Klinikum der Universität
      • München, Alemanha, 81675
        • Klinikum rechts der Isar der Technischen Universitaet Muenchen
  • Argentina
      • Buenos Aires, Argentina, C1141ACG
        • Helios Salud S.A.
      • Buenos Aires, Argentina, C1202ABB
        • Fundacion Huesped
      • Santa Fe, Argentina, S2000PBJ,
        • Instituto CAICI SRL
  • Austrália
    • New South Wales
      • Darlinghurst, New South Wales, Austrália, 2011
        • Taylor Square Private Clinic
    • Victoria
      • Melbourne, Victoria, Austrália, 3004
        • Alfred Hospital(Alfred Health)
      • South Yarra, Victoria, Austrália, 3141
        • Prahran Market Clinic
  • Canadá
      • Decarie Montreal, Canadá, H4A 3J1
        • Chronic Viral Illness Service/McGill University Health Centre (MUHC)
      • Montreal, Canadá, H2L 4P9
        • Clinique Médicale l'Actuel
      • Ottawa, Canadá, K1H 8L6
        • The Ottawa Hospital - General Campus
      • Regina, Canadá, S4P 0W5
        • Regina General Hospital
      • Vancouver, Canadá, V6Z1Y6
        • St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
      • Victoria, Canadá, V8W 1M8
        • Cool Aid Community Health Centre
  • Coréia do Sul
      • Daegu, Coréia do Sul, 41944
        • Kyungpook National University Hospital
      • Seoul, Coréia do Sul, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Coréia do Sul, *04564
        • National Medical Center
      • Seoul, Coréia do Sul, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Espanha
      • Badalona Barcelona, Espanha, 8916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Espanha, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Espanha, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Espanha, 28046
        • Hospital Universitario La Paz - PPDS
      • Seville, Espanha, 4103
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Espanha, 46014
        • Consorcio Hospital General Universitario de Valencia
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85015
        • Pueblo Family Physicians
    • California
      • Berkeley, California, Estados Unidos, 48072
        • Be Well Medical Center
      • Beverly Hills, California, Estados Unidos, 90211
        • Pacific Oaks Medical Group
      • Los Angeles, California, Estados Unidos, 90036
        • Ruane Clinical Research Group Inc.
      • Oakland, California, Estados Unidos, 94609
        • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
      • Palm Springs, California, Estados Unidos, 92262
        • BIOS Clinical Research
      • San Diego, California, Estados Unidos, 92103
        • UCSD Anti Viral Research Centre (AVRC)
      • Torrance, California, Estados Unidos, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
      • West Hollywood, California, Estados Unidos, 90046
        • Mills Clinical Research
    • Colorado
      • Denver, Colorado, Estados Unidos, 80204
        • Public Health Institute at Denver Health
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale University School of Medicine (study visits)
    • Florida
      • DeLand, Florida, Estados Unidos, 32720
        • Midland Florida Infectious Diseases Specialists, PL - Orange City
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Therafirst Medical Center
      • Fort Lauderdale, Florida, Estados Unidos, 33316
        • CAN Community Health
      • Ft. Pierce, Florida, Estados Unidos, 34982
        • Midway Immunology and Research Center
      • Miami, Florida, Estados Unidos, 33133
        • AIDS Healthcare Foundation - The Kinder Medical Group
      • Miami, Florida, Estados Unidos, 33136
        • Schiff Center for liver Diseases/University of Miami
      • Miami Lakes, Florida, Estados Unidos, 33016
        • Floridian Clinical Research
      • Orlando, Florida, Estados Unidos, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Estados Unidos, 32806
        • Bliss Healthcare
      • Pensacola, Florida, Estados Unidos, 32503
        • AHF Pensacola
      • Sarasota, Florida, Estados Unidos, 34237
        • CAN community Health
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Triple O Research Institute, P.A.
    • Georgia
      • Decatur, Georgia, Estados Unidos, 30033
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, Estados Unidos, 31201
        • Mercer University, Department of Internal Medicine
    • Massachusetts
      • Springfield, Massachusetts, Estados Unidos, 01105
        • Claudia T Martorell MD LLC dba The Research Institute
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Health
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • KC Care health Center
      • St Louis, Missouri, Estados Unidos, 63139
        • Southampton Community Healthcare, Inc.
    • New Jersey
      • Hillsborough, New Jersey, Estados Unidos, 08844
        • ID Care, LLC
      • Newark, New Jersey, Estados Unidos, 07102
        • Saint Michael's Medical Center
      • Newark, New Jersey, Estados Unidos, 07103
        • New Jersey Medical School - Clinical Research Center
      • Somers Point, New Jersey, Estados Unidos, 08244
        • South Jersey Infectious Disease
    • New Mexico
      • Santa Fe, New Mexico, Estados Unidos, 87505
        • AXCES Research Group, LLC
    • New York
      • Flushing, New York, Estados Unidos, 11355
        • New York-Presbyterian Queens
      • The Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center
    • North Carolina
      • Greenville, North Carolina, Estados Unidos, 27858
        • The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Rosedale Health and Wellness
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Philadelphia FIGHT Community Health Centers
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina (MUSC) Research Nexus
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Central Texas Clinical Research
      • Bellaire, Texas, Estados Unidos, 77401
        • St Hope Foundation, Inc.
      • Dallas, Texas, Estados Unidos, 75208
        • AIDS Arms, Inc. DBA Prism Health North Texas
      • Dallas, Texas, Estados Unidos, 75246
        • North Texas Infectious Diseases Consultants, PA
      • El Paso, Texas, Estados Unidos, 79902
        • AXCES Research Group, LLC
      • Fort Worth, Texas, Estados Unidos, 76104
        • Texas Centers for Infectious Disease Associates
      • Houston, Texas, Estados Unidos, 77098
        • The Crofoot research Center, INC.
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84102
        • AXCES Research Group, LLC
    • Virginia
      • Annandale, Virginia, Estados Unidos, 22003
        • Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Peter Shalit MD
      • Tacoma, Washington, Estados Unidos, 98405
        • Community Health care
  • Itália
      • Brescia, Itália, 25123
        • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
      • Foggia, Itália, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
      • Milan, Itália, 20127
        • IRCCS Ospedale San Raffaele
      • Monza, Itália, 20090
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
      • Pavia, Itália, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Roma, Itália, 00168
        • Fondazione Policlinico Universitario A Gemelli-Rome
      • Roma, Itália, 00149
        • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
  • Japão
      • Aichi, Japão, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Osaka, Japão, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Tokyo, Japão, 162-0052
        • Center Hospital of the National Center for Global Health and Medicine
  • México
      • Mexico City, México, 6170
        • ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
      • Mérida, México, 97070
        • Unidad de Atencion Medica e Investigacion en Salud
  • Porto Rico
    • PR
      • San Juan, PR, Porto Rico, 00935
        • Proyecto ACTU
      • San Juan, PR, Porto Rico, 00909
        • HOPE Clinical Research
  • Reino Unido
      • Liverpool, Reino Unido, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
      • London, Reino Unido, WC1E 6JB
        • Mortimer Market Centre
      • London, Reino Unido, SE5 9RS
        • King's College Hospital, Weston Education Centre
      • London, Reino Unido, SW109NH
        • Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
      • London, Reino Unido, W2 1NY
        • St Mary's Hospital - PPDS
  • República Dominicana
      • Santo Domingo, República Dominicana
        • Instituto Dominicano de Estudios Virologicos - IDEV
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 33004
        • Taoyuan General Hospital, Ministry of Health and Welfare

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

  • Currently receiving B/F/TAF for at least 6 months prior to screening.
  • If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
  • At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
  • No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
  • Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Key Exclusion Criteria:

  • Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.

  • Breastfeeding (nursing).

  • Prior use of, or exposure to, LEN.

  • Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.

  • Active tuberculosis infection.

  • Acute hepatitis < 30 days before randomization.

  • Chronic hepatitis B virus (HBV) infection, as determined by either:

    • Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
    • Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.

  • Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.

  • History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).

  • Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.

  • Active malignancy requiring acute systemic therapy.

  • Any of the following laboratory values at screening:

    • Alanine aminotransferase > 5 × upper limit of normal (ULN).
    • Direct bilirubin > 1.5 × ULN.
    • Platelets < 50,000/mm^3.
    • Hemoglobin < 8.0 g/dL.

  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.

  • Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.

  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Blinded Phase: Treatment Group 1: BIC/LEN 75/50 mg

Participants will switch from bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablets to bictegravir/lenacapavir (BIC/LEN) 75/50 mg FDC tablets + placebo-to-match (PTM) B/F/TAF tablets, administered orally, once daily up to 48 weeks. Participants will also receive a 2-day oral pharmacokinetic (PK) loading dose of LEN 600 mg on Days 1 and 2, in addition to the daily doses of BIC/LEN 75/50 mg and PTM B/F/TAF tablets starting on Day 1.

At the end of blinded treatment (EBT) participants will enter the open label (OL) phase and continue to receive BIC/LEN 75 mg/50 mg FDC tablets through at least 48 weeks in the OL phase. At the OL Week 48, participants will be given an option to continue to receive BIC/LEN FDC tablets.
Medicamento: Lenacapavir

Tablets administered orally without regard to food

Outros nomes:
  • GS-6207
Medicamento: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Outros nomes:
  • Bixlenvo™
Medicamento: Placebo to match B/F/TAF

Tablets administered orally without regard to food
Comparador Ativo: Blinded Phase: Treatment Group 2: B/F/TAF 50/200/25 mg

Participants will continue with their B/F/TAF 50/200/25 mg tablets and start PTM BIC/LEN tablets on Day 1 administered orally, once daily up to 48 weeks. Participants will receive PTM oral LEN PK loading tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2).

Participants who complete the EBT will be given an option to enter the OL phase to receive BIC/LEN FDC tablets.
Medicamento: B/F/TAF

Tablets administered orally without regard to food

Outros nomes:
  • Biktarvy®
Medicamento: Placebo to match BIC/LEN FDC

Tablets administered orally without regard to food

Medicamento: Placebo to match Lenacapavir

Tablets administered orally without regard to food
Experimental: Open-label Phase: BIC/LEN 75/50mg

Participants from Treatment Group 1 will receive BIC/LEN FDC tablets through at least OL Week 48. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets. Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets. Participants from Treatment Group 2 who enter the OL phase will also receive a 2-day oral loading dose of LEN 600 mg (2 × 300 mg LEN on Day 1 and on Day 2).

All participants who enter the OL phase may continue to receive BIC/LEN FDC tablets daily until study drug is available or until Gilead Sciences (Gilead) elects to discontinue the study.
Medicamento: Lenacapavir

Tablets administered orally without regard to food

Outros nomes:
  • GS-6207
Medicamento: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Outros nomes:
  • Bixlenvo™

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 48 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm
Prazo: Week 48

Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and participants who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than adverse event (AE), death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window was between Days 295 and 378 (inclusively). Percentages were rounded off.
Week 48

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
Prazo: Week 48

Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 48 analysis window were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.
Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
Prazo: Baseline, Week 48
Baseline, Week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Prazo: First dose date up to Week 48

An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC/LEN FDC, Treatment Group 1) or 30 days (for B/F/TAF, Treatment Group 2) or any AE leading to study drug discontinuation. Percentages were rounded off.
First dose date up to Week 48
Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm
Prazo: Week 96
Week 96
Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by US FDA-Defined Snapshot Algorithm
Prazo: Week 96
Week 96
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 96
Prazo: Week 96
Week 96
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 96
Prazo: First dose date up to Week 96
First dose date up to Week 96
Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-Defined Snapshot Algorithm
Prazo: Week 144
Week 144
Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by US FDA-Defined Snapshot Algorithm
Prazo: Week 144
Week 144
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 144
Prazo: Week 144
Week 144
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 144
Prazo: First dose date up to Week 144
First dose date up to Week 144

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Gilead Sciences

Investigadores

  • Diretor de estudo: Gilead Study Director, Gilead Sciences

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de março de 2024

Conclusão Primária (Real)

27 de outubro de 2025

Conclusão do estudo (Estimado)

1 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

20 de março de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de março de 2024

Primeira postagem (Real)

27 de março de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GS-US-621-6290
  • 2023-510022-33 (Outro identificador: European Medicines Agency)
  • jRCT2051240046 (Identificador de registro: Japan Registry)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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