Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um Estudo Clínico de Islatravir e Ulonivirine para Pessoas com VIH-1 que Não Tenham Sido Tratadas Anteriormente (MK-8591B-062)

2 de novembro de 2026 atualizado por: Merck Sharp & Dohme LLC

Um Estudo de Fase 2/3, Randomizado, Controlado Ativamente, Aberto (Fase 2) e Duplo-Cego (Fase 3) para Avaliar a Atividade Antirretroviral, Segurança e Tolerabilidade de Islatravir (ISL) e Ulonivirina (ULO) Uma Vez por Semana Comparado com Bictegravir/Emtricitabina/Tenofovir Alafenamida (BIC/FTC/TAF) Uma Vez por Dia em Participantes Adultos Naïve ao Tratamento que Vivem com HIV-1

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

570

Estágio

  • Fase 2
  • 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.

Contato de estudo

Locais de estudo

  • Argentina
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1427CEA
        • Recrutamento
        • Fundación Huesped ( Site 3100)
        • Contato:
          • Study Coordinator
          • Número de telefone: +541121209999
      • Caba, Buenos Aires, Argentina, C1425AGC
        • Recrutamento
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
        • Contato:
          • Study Coordinator
          • Número de telefone: +5491141639539
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Recrutamento
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
        • Contato:
          • Study Coordinator
          • Número de telefone: +5492234365218
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1405CKC
        • Recrutamento
        • Fundación IDEAA ( Site 3101)
        • Contato:
          • Study Coordinator
          • Número de telefone: +5491161835390
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Recrutamento
        • Instituto CAICI SRL ( Site 3106)
        • Contato:
          • Study Coordinator
          • Número de telefone: +543414248045
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
        • Recrutamento
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
        • Contato:
          • Study Coordinator
          • Número de telefone: +5403814502600
  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 2T1
        • Concluído
        • Spectrum Health ( Site 3307)
    • Quebec
      • Montreal, Quebec, Canadá, H2L 4P9
        • Recrutamento
        • Gestion clinique médicale l'Actuel ( Site 3303)
        • Contato:
          • Study Coordinator
          • Número de telefone: 5145243642x2271
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500710
        • Recrutamento
        • Biomedica Research Group ( Site 4201)
        • Contato:
          • Study Coordinator
          • Número de telefone: 56222045686
      • Santiago, Region M. de Santiago, Chile, 7620157
        • Recrutamento
        • Clínica Universidad de Los Andes ( Site 4207)
        • Contato:
          • Study Coordinator
          • Número de telefone: 56226183123
      • Santiago, Region M. de Santiago, Chile, 7770086
        • Ativo, não recrutando
        • Espacio Eme ( Site 4202)
  • Espanha
      • Barcelona, Espanha, 08035
        • Recrutamento
        • Hospital Universitari Vall d'Hebron ( Site 3402)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34934894377
      • Barcelona, Espanha, 08036
        • Recrutamento
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34932275574
      • Madrid, Espanha, 28041
        • Recrutamento
        • Hospital Universitario 12 de Octubre ( Site 3405)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34917792853
      • Málaga, Espanha, 29010
        • Recrutamento
        • Complejo Hospitalario Virgen De La Victoria ( Site 3409)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34 951032594
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Espanha, 28029
        • Recrutamento
        • Hospital Universitario La Paz ( Site 3404)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34915383515
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Espanha, 46014
        • Recrutamento
        • Consorcio Hospital General Universitario de Valencia ( Site 3406)
        • Contato:
          • Study Coordinator
          • Número de telefone: +34 963131800x437834
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90036
        • Recrutamento
        • Ruane Clinical Research Group, Inc. ( Site 1513)
        • Contato:
          • Study Coordinator
          • Número de telefone: 323-954-0400
    • Colorado
      • Denver, Colorado, Estados Unidos, 80246
        • Recrutamento
        • Vivent Health ( Site 1519)
        • Contato:
          • Study Coordinator
          • Número de telefone: 303-393-8050
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20032
        • Recrutamento
        • Whitman-Walker Institute ( Site 1538)
        • Contato:
          • Study Coordinator
          • Número de telefone: 202-207-2510
    • Florida
      • Ft. Pierce, Florida, Estados Unidos, 34982
        • Recrutamento
        • Midway Immunology and Research Center ( Site 1503)
        • Contato:
          • Study Coordinator
          • Número de telefone: 772-595-9830
      • Miami Gardens, Florida, Estados Unidos, 33055
        • Recrutamento
        • CAN Community Health- Miami Gardens ( Site 1549)
        • Contato:
          • Study Coordinator
          • Número de telefone: 954-955-0023
      • Orlando, Florida, Estados Unidos, 32803
        • Recrutamento
        • Orlando Immunology Center ( Site 1501)
        • Contato:
          • Study Coordinator
          • Número de telefone: 407-374-0220
      • Sarasota, Florida, Estados Unidos, 34237
        • Recrutamento
        • CAN Community Health ( Site 1510)
        • Contato:
          • Study Coordinator
          • Número de telefone: 941-366-0134
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Recrutamento
        • Triple O Research Institute ( Site 1505)
        • Contato:
          • Study Coordinator
          • Número de telefone: 561-855-7871
    • Georgia
      • Decatur, Georgia, Estados Unidos, 30033
        • Recrutamento
        • Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
        • Contato:
          • Study Coordinator
          • Número de telefone: 404-297-9755
      • Macon, Georgia, Estados Unidos, 31201
        • Recrutamento
        • Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
        • Contato:
          • Study Coordinator
          • Número de telefone: 478-301-5846
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • Rush University Medical Center-Infectious Disease ( Site 1522)
        • Contato:
          • Study Coordinator
          • Número de telefone: 312-942-5865
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Hospital ( Site 1535)
        • Contato:
          • Study Coordinator
          • Número de telefone: 313-916-2600
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Recrutamento
        • KC CARE Health Center ( Site 1506)
        • Contato:
          • Study Coordinator
          • Número de telefone: 816-753-5144
    • New Jersey
      • Hillsborough, New Jersey, Estados Unidos, 08844
        • Recrutamento
        • ID Care ( Site 1507)
        • Contato:
          • Study Coordinator
          • Número de telefone: 908-281-0221
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Recrutamento
        • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
        • Contato:
          • Study Coordinator
          • Número de telefone: 704-468-3510
      • Greensboro, North Carolina, Estados Unidos, 27401
        • Recrutamento
        • Regional Center for Infectious Diseases ( Site 1516)
        • Contato:
          • Study Coordinator
          • Número de telefone: 336-832-3275
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • The Ohio State University ( Site 1536)
        • Contato:
          • Study Coordinator
          • Número de telefone: 614-293-8112
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • University of Pennsylvania Perelman School of Medicine ( Site 1508)
        • Contato:
          • Study Coordinator
          • Número de telefone: 215-349-8092
    • Texas
      • Bellaire, Texas, Estados Unidos, 77401
        • Recrutamento
        • Saint Hope Foundation, Inc. ( Site 1504)
        • Contato:
          • Study Coordinator
          • Número de telefone: 713-839-7111
      • Dallas, Texas, Estados Unidos, 75208
        • Recrutamento
        • Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
        • Contato:
          • Study Coordinator
          • Número de telefone: 214-521-5191
      • Dallas, Texas, Estados Unidos, 75246
        • Ativo, não recrutando
        • North Texas Infectious Diseases Consultants ( Site 1500)
      • Fort Worth, Texas, Estados Unidos, 76104
        • Recrutamento
        • Texas Center for Infectious Disease Associates ( Site 1502)
        • Contato:
          • Study Coordinator
          • Número de telefone: 817-348-0042
      • Longview, Texas, Estados Unidos, 75605
        • Recrutamento
        • DCOL Center for Clinical Research ( Site 1511)
        • Contato:
          • Study Coordinator
          • Número de telefone: 903-238-8854
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Recrutamento
        • Harborview Medical Center ( Site 1526)
        • Contato:
          • Study Coordinator
          • Número de telefone: 206-744-8886
  • França
    • Gironde
      • Bordeaux, Gironde, França, 33076
        • Recrutamento
        • Bordeaux University Hospital - Pellegrin ( Site 3605)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33556795536
    • Haute-Garonne
      • Toulouse, Haute-Garonne, França, 31059
        • Recrutamento
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33561776800
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, França, 44093
        • Recrutamento
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33240083109
    • Rhone
      • Lyon, Rhone, França, 69317
        • Recrutamento
        • HOPITAL DE LA CROIX ROUSSE ( Site 3613)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33472071107
    • Île-de-France Region
      • Bobigny, Île-de-France Region, França, 93000
        • Recrutamento
        • Hôpital Avicenne ( Site 3602)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33148955421
      • Paris, Île-de-France Region, França, 75018
        • Recrutamento
        • Hôpital Bichat - Claude-Bernard ( Site 3601)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33140257803
      • Paris, Île-de-France Region, França, 75010
        • Recrutamento
        • Hôpital Saint-Louis ( Site 3600)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33142494852
  • Guatemala
      • Guatemala City, Guatemala, 01009
        • Recrutamento
        • MEDI-K ( Site 3803)
        • Contato:
          • Study Coordinator
          • Número de telefone: +50222912323
      • Guatemala City, Guatemala, 01009
        • Recrutamento
        • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
        • Contato:
          • Study Coordinator
          • Número de telefone: +50223196600
      • Guatemala City, Guatemala, 01010
        • Recrutamento
        • CELAN,S.A ( Site 3802)
        • Contato:
          • Study Coordinator
          • Número de telefone: +50222968018
  • México
      • Veracruz, México, 91910
        • Recrutamento
        • Arké SMO S.A de C.V ( Site 4505)
        • Contato:
          • Study Coordinator
          • Número de telefone: +522299314102
    • Guanajuato
      • León, Guanajuato, México, 37000
        • Recrutamento
        • Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
        • Contato:
          • Study Coordinator
          • Número de telefone: 4777160714
  • África do Sul
    • Free State
      • Bloemfontein, Free State, África do Sul, 9301
        • Recrutamento
        • Josha Research ( Site 4302)
        • Contato:
          • Study Coordinator
          • Número de telefone: +27 51 412 8160
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, África do Sul, 4052
        • Recrutamento
        • Wentworth Hospital ( Site 4303)
        • Contato:
          • Study Coordinator
          • Número de telefone: +27837471149
    • Western Cape
      • Mbekweni, Paarl, Western Cape, África do Sul, 7646
        • Recrutamento
        • Be Part Yoluntu Centre ( Site 4300)
        • Contato:
          • Study Coordinator
          • Número de telefone: +27 21 8683990/1/2

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

Inclusion Criteria:

  • Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
  • Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 and ≤1,000,000 copies/mL
  • Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3.
  • Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

Exclusion Criteria:

  • Has human immunodeficiency virus type 2 (HIV-2) infection.
  • Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
  • Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
  • Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
  • Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

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: Phase 2: ISL + ULO

Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
Medicamento: ISL

ISL 2 x 1 mg oral capsules administered qw for 96 weeks

Outros nomes:
  • MK-8591
  • islatravir
Medicamento: ULO

ULO 2 x 100 mg oral tablets administered qw for 96 weeks

Outros nomes:
  • MK-8507
  • ulonivirina
Comparador Ativo: Phase 2: BIC/FTC/TAF

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
Medicamento: BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

Outros nomes:
  • BIKTARVY®
  • bictegravir/emtricitabina/tenofovir alafenamida
Experimental: Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF

ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
Medicamento: Placebo for BIC/FTC/TAF

BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

Medicamento: ISL/ULO

ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Outros nomes:
  • MK-8591B
Comparador Ativo: Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO

BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
Medicamento: BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

Outros nomes:
  • BIKTARVY®
  • bictegravir/emtricitabina/tenofovir alafenamida
Medicamento: Placebo to ISL/ULO

ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Prazo: Week 24

Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 24.
Week 24
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
Prazo: Week 24

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Week 24
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
Prazo: Week 24

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Week 24
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Prazo: Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 48.
Week 48
Phase 3: Percentage of Participants Who Experience an AE at Week 48
Prazo: Week 48

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Week 48
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
Prazo: Week 48

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Week 48

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Prazo: Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 48.
Week 48
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Prazo: Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 96.
Week 96
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
Prazo: Week 24

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 24.
Week 24
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
Prazo: Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 48.
Week 48
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Prazo: Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 96.
Week 96
Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24
Prazo: Baseline (Day 1) and Week 24

Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 24 weeks.
Baseline (Day 1) and Week 24
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
Prazo: Baseline (Day 1) and Week 48

Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks.
Baseline (Day 1) and Week 48
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
Prazo: Baseline (Day 1) and Week 96

Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks.
Baseline (Day 1) and Week 96
Phase 2: Percentage of Participants Who Experience an AE
Prazo: Up to approximately 102 weeks

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 102 weeks
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE
Prazo: Up to approximately 96 weeks

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 96 weeks
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24
Prazo: Week 24

Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 24 will be presented.
Week 24
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
Prazo: Week 48

Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented.
Week 48
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
Prazo: Week 96

Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented.
Week 96
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Prazo: Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 96.
Week 96
Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
Prazo: Week 48

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 48.
Week 48
Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Prazo: Week 96

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 96.
Week 96
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48
Prazo: Baseline (Day 1) and Week 48

Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks.
Baseline (Day 1) and Week 48
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96
Prazo: Baseline (Day 1) and Week 96

Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks.
Baseline (Day 1) and Week 96
Phase 3: Percentage of Participants Who Experience an AE
Prazo: Up to approximately 102 weeks

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 102 weeks
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE
Prazo: Up to approximately 96 weeks

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 96 weeks
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
Prazo: Week 48

Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented.
Week 48
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
Prazo: Week 96

Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented.
Week 96
Phase 3: Mean Change From Baseline in Body Weight at Week 48
Prazo: Baseline (Day 1) and Week 48

Body weight will be collected throughout the study.
Baseline (Day 1) and Week 48
Phase 3: Mean Change From Baseline in Body Weight at Week 96
Prazo: Baseline (Day 1) and Week 96

Body weight will be collected throughout the study.
Baseline (Day 1) and Week 96

Colaboradores e Investigadores

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

Patrocinador

Merck Sharp & Dohme LLC

Investigadores

  • Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC

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.

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)

18 de dezembro de 2025

Conclusão Primária (Estimado)

1 de fevereiro de 2029

Conclusão do estudo (Estimado)

18 de dezembro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

1 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de dezembro de 2025

Primeira postagem (Real)

5 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 8591B-062
  • U1111-1323-4689 (Identificador de registro: UTN)
  • 2025-522519-40 (Identificador de registro: EU CT)
  • MK-8591B-062 (Outro identificador: MSD)
  • 2025 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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 .

Se inscrever