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Uno Studio Clinico su Islatravir e Ulonivirine per Persone con HIV-1 Non Trattate in Precedenza (MK-8591B-062)

9 ottobre 2026 aggiornato da: Merck Sharp & Dohme LLC

Studio di Fase 2/3, Randomizzato, Controllato con Farmaco Attivo, in Aperto (Fase 2) e in Doppio Cieco (Fase 3) per Valutare l'Attività Antiretrovirale, la Sicurezza e la Tollerabilità di Islatravir (ISL) e Ulonivirina (ULO) Somministrati Una Volta a Settimana Confrontati con Bictegravir/Emtricitabina/Tenofovir Alafenamide (BIC/FTC/TAF) Somministrati Una Volta al Giorno in Partecipanti Adulti Naïve al Trattamento Affetti da 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

570

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Altri nomi:
  • MK-8591
  • islatravir
Droga: ULO

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

Altri nomi:
  • MK-8507
  • ulonivirina
Comparatore attivo: 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

Altri nomi:
  • BIKTARVY®
  • bictegravir/emtricitabina/tenofovir alafenamide
Sperimentale: 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

Altri nomi:
  • MK-8591B
Comparatore attivo: 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

Altri nomi:
  • BIKTARVY®
  • bictegravir/emtricitabina/tenofovir alafenamide
Droga: Placebo to ISL/ULO

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1) and Week 96

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Investigatori

  • Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 dicembre 2025

Completamento primario (Stimato)

1 febbraio 2029

Completamento dello studio (Stimato)

18 dicembre 2031

Date di iscrizione allo studio

Primo inviato

1 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2025

Primo Inserito (Effettivo)

5 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 8591B-062
  • U1111-1323-4689 (Identificatore di registro: UTN)
  • 2025-522519-40 (Identificatore di registro: EU CT)
  • MK-8591B-062 (Altro identificatore: MSD)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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