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Un Estudio Clínico de Islatravir y Ulonivirina para Personas con VIH-1 que No Han Sido Tratadas Anteriormente (MK-8591B-062)

9 de octubre de 2026 actualizado por: Merck Sharp & Dohme LLC

Estudio de fase 2/3, aleatorizado, controlado activamente, de etiqueta abierta (fase 2) y doble ciego (fase 3) para evaluar la actividad antirretroviral, la seguridad y la tolerabilidad de islatravir (ISL) y ulonivirina (ULO) una vez a la semana en comparación con bictegravir/emtricitabina/tenofovir alafenamida (BIC/FTC/TAF) una vez al día en participantes adultos sin tratamiento previo que viven con el VIH-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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

570

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Toll Free Number
  • Número de teléfono: 1-888-577-8839
  • Correo electrónico: Trialsites@msd.com

Ubicaciones de estudio

  • Argentina
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1427CEA
        • Reclutamiento
        • Fundación Huesped ( Site 3100)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +541121209999
      • Caba, Buenos Aires, Argentina, C1425AGC
        • Reclutamiento
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +5491141639539
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Reclutamiento
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +5492234365218
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1405CKC
        • Reclutamiento
        • Fundación IDEAA ( Site 3101)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +5491161835390
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Reclutamiento
        • Instituto CAICI SRL ( Site 3106)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +543414248045
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
        • Reclutamiento
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +5403814502600
  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 2T1
        • Reclutamiento
        • Spectrum Health ( Site 3307)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 6046853747
    • Quebec
      • Montreal, Quebec, Canadá, H2L 4P9
        • Reclutamiento
        • Gestion clinique médicale l'Actuel ( Site 3303)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 5145243642x2271
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500710
        • Reclutamiento
        • Biomedica Research Group ( Site 4201)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 56222045686
      • Santiago, Region M. de Santiago, Chile, 7620157
        • Reclutamiento
        • Clínica Universidad de Los Andes ( Site 4207)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 56226183123
      • Santiago, Region M. de Santiago, Chile, 7770086
        • Activo, no reclutando
        • Espacio Eme ( Site 4202)
  • España
      • Barcelona, España, 08035
        • Reclutamiento
        • Hospital Universitari Vall d'Hebron ( Site 3402)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34934894377
      • Barcelona, España, 08036
        • Reclutamiento
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34932275574
      • Madrid, España, 28041
        • Reclutamiento
        • Hospital Universitario 12 de Octubre ( Site 3405)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34917792853
      • Málaga, España, 29010
        • Reclutamiento
        • Complejo Hospitalario Virgen De La Victoria ( Site 3409)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34 951032594
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, España, 28029
        • Reclutamiento
        • Hospital Universitario La Paz ( Site 3404)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34915383515
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, España, 46014
        • Reclutamiento
        • Consorcio Hospital General Universitario de Valencia ( Site 3406)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +34 963131800x437834
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90036
        • Reclutamiento
        • Ruane Clinical Research Group, Inc. ( Site 1513)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 323-954-0400
    • Colorado
      • Denver, Colorado, Estados Unidos, 80246
        • Reclutamiento
        • Vivent Health ( Site 1519)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 303-393-8050
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20032
        • Reclutamiento
        • Whitman-Walker Institute ( Site 1538)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 202-207-2510
    • Florida
      • Ft. Pierce, Florida, Estados Unidos, 34982
        • Reclutamiento
        • Midway Immunology and Research Center ( Site 1503)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 772-595-9830
      • Miami Gardens, Florida, Estados Unidos, 33055
        • Reclutamiento
        • CAN Community Health- Miami Gardens ( Site 1549)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 954-955-0023
      • Orlando, Florida, Estados Unidos, 32803
        • Reclutamiento
        • Orlando Immunology Center ( Site 1501)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 407-374-0220
      • Sarasota, Florida, Estados Unidos, 34237
        • Reclutamiento
        • CAN Community Health ( Site 1510)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 941-366-0134
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Reclutamiento
        • Triple O Research Institute ( Site 1505)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 561-855-7871
    • Georgia
      • Decatur, Georgia, Estados Unidos, 30033
        • Reclutamiento
        • Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 404-297-9755
      • Macon, Georgia, Estados Unidos, 31201
        • Reclutamiento
        • Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 478-301-5846
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Reclutamiento
        • Rush University Medical Center-Infectious Disease ( Site 1522)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 312-942-5865
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Hospital ( Site 1535)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 313-916-2600
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Reclutamiento
        • KC CARE Health Center ( Site 1506)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 816-753-5144
    • New Jersey
      • Hillsborough, New Jersey, Estados Unidos, 08844
        • Reclutamiento
        • ID Care ( Site 1507)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 908-281-0221
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Reclutamiento
        • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 704-468-3510
      • Greensboro, North Carolina, Estados Unidos, 27401
        • Reclutamiento
        • Regional Center for Infectious Diseases ( Site 1516)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 336-832-3275
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • The Ohio State University ( Site 1536)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 614-293-8112
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Reclutamiento
        • University of Pennsylvania Perelman School of Medicine ( Site 1508)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 215-349-8092
    • Texas
      • Bellaire, Texas, Estados Unidos, 77401
        • Reclutamiento
        • Saint Hope Foundation, Inc. ( Site 1504)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 713-839-7111
      • Dallas, Texas, Estados Unidos, 75208
        • Reclutamiento
        • Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 214-521-5191
      • Dallas, Texas, Estados Unidos, 75246
        • Activo, no reclutando
        • North Texas Infectious Diseases Consultants ( Site 1500)
      • Fort Worth, Texas, Estados Unidos, 76104
        • Reclutamiento
        • Texas Center for Infectious Disease Associates ( Site 1502)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 817-348-0042
      • Longview, Texas, Estados Unidos, 75605
        • Reclutamiento
        • DCOL Center for Clinical Research ( Site 1511)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 903-238-8854
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Reclutamiento
        • Harborview Medical Center ( Site 1526)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 206-744-8886
  • Francia
    • Gironde
      • Bordeaux, Gironde, Francia, 33076
        • Reclutamiento
        • Bordeaux University Hospital - Pellegrin ( Site 3605)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33556795536
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Francia, 31059
        • Reclutamiento
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33561776800
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Francia, 44093
        • Reclutamiento
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33240083109
    • Rhone
      • Lyon, Rhone, Francia, 69317
        • Reclutamiento
        • HOPITAL DE LA CROIX ROUSSE ( Site 3613)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33472071107
    • Île-de-France Region
      • Bobigny, Île-de-France Region, Francia, 93000
        • Reclutamiento
        • Hôpital Avicenne ( Site 3602)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33148955421
      • Paris, Île-de-France Region, Francia, 75018
        • Reclutamiento
        • Hôpital Bichat - Claude-Bernard ( Site 3601)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33140257803
      • Paris, Île-de-France Region, Francia, 75010
        • Reclutamiento
        • Hôpital Saint-Louis ( Site 3600)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +33142494852
  • Guatemala
      • Guatemala City, Guatemala, 01009
        • Reclutamiento
        • MEDI-K ( Site 3803)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +50222912323
      • Guatemala City, Guatemala, 01009
        • Reclutamiento
        • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +50223196600
      • Guatemala City, Guatemala, 01010
        • Reclutamiento
        • CELAN,S.A ( Site 3802)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +50222968018
  • México
    • Guanajuato
      • León, Guanajuato, México, 37000
        • Reclutamiento
        • Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: 4777160714
  • Sudáfrica
    • Free State
      • Bloemfontein, Free State, Sudáfrica, 9301
        • Reclutamiento
        • Josha Research ( Site 4302)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +27 51 412 8160
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sudáfrica, 4052
        • Reclutamiento
        • Wentworth Hospital ( Site 4303)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +27837471149
    • Western Cape
      • Mbekweni, Paarl, Western Cape, Sudáfrica, 7646
        • Reclutamiento
        • Be Part Yoluntu Centre ( Site 4300)
        • Contacto:
          • Study Coordinator
          • Número de teléfono: +27 21 8683990/1/2

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Phase 2: ISL + ULO

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

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

Otros nombres:
  • MK-8591
  • islatravir
Droga: ULO

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

Otros nombres:
  • MK-8507
  • ulonivirina
Comparador activo: Phase 2: BIC/FTC/TAF

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

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

Otros nombres:
  • 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
Droga: Placebo for BIC/FTC/TAF

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

Droga: ISL/ULO

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

Otros nombres:
  • MK-8591B
Comparador activo: 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
Droga: BIC/FTC/TAF

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

Otros nombres:
  • BIKTARVY®
  • bictegravir/emtricitabina/tenofovir alafenamida
Droga: Placebo to ISL/ULO

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Day 1) and Week 96

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck Sharp & Dohme LLC

Investigadores

  • Director de estudio: Medical Director, Merck Sharp & Dohme LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de diciembre de 2025

Finalización primaria (Estimado)

1 de febrero de 2029

Finalización del estudio (Estimado)

18 de diciembre de 2031

Fechas de registro del estudio

Enviado por primera vez

1 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

1 de diciembre de 2025

Publicado por primera vez (Actual)

5 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 8591B-062
  • U1111-1323-4689 (Identificador de registro: UTN)
  • 2025-522519-40 (Identificador de registro: EU CT)
  • MK-8591B-062 (Otro identificador: MSD)
  • 2025 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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