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Een klinische studie van Islatravir en Ulonivirine voor mensen met HIV-1 die nog niet eerder zijn behandeld (MK-8591B-062)

9 oktober 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een fase 2/3, gerandomiseerde, actief-gecontroleerde, open-label (fase 2) en dubbelblinde (fase 3) studie om de antiretrovirale activiteit, veiligheid en verdraagbaarheid van Islatravir (ISL) en Ulonivirine (ULO) eenmaal per week te evalueren in vergelijking met Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) eenmaal per dag bij behandelingsnaïeve volwassen deelnemers die leven met 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

570

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 2: ISL + ULO

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

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

Andere namen:
  • MK-8591
  • islatravir
Geneesmiddel: ULO

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

Andere namen:
  • MK-8507
  • ulonivirine
Actieve vergelijker: Phase 2: BIC/FTC/TAF

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

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

Andere namen:
  • BIKTARVY®
  • bictegravir/emtricitabine/tenofoviralafenamide
Experimenteel: 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
Geneesmiddel: Placebo for BIC/FTC/TAF

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

Geneesmiddel: ISL/ULO

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

Andere namen:
  • MK-8591B
Actieve vergelijker: 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
Geneesmiddel: BIC/FTC/TAF

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

Andere namen:
  • BIKTARVY®
  • bictegravir/emtricitabine/tenofoviralafenamide
Geneesmiddel: Placebo to ISL/ULO

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline (Day 1) and Week 96

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 december 2025

Primaire voltooiing (Geschat)

1 februari 2029

Studie voltooiing (Geschat)

18 december 2031

Studieregistratiedata

Eerst ingediend

1 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

1 december 2025

Eerst geplaatst (Werkelijk)

5 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

9 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 8591B-062
  • U1111-1323-4689 (Register-ID: UTN)
  • 2025-522519-40 (Register-ID: EU CT)
  • MK-8591B-062 (Andere identificatie: MSD)
  • 2025 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren