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En klinisk undersøgelse af Islatravir og Ulonivirine til personer med HIV-1, der ikke tidligere har fået behandling (MK-8591B-062)

2. november 2026 opdateret af: Merck Sharp & Dohme LLC

En fase 2/3, randomiseret, aktivt-kontrolleret, åben (fase 2) og dobbeltblind (fase 3) undersøgelse for at evaluere antiretroviral aktivitet, sikkerhed og tolerabilitet af Islatravir (ISL) og Ulonivirine (ULO) én gang ugentligt sammenlignet med Bictegravir/Emtricitabin/Tenofovir Alafenamid (BIC/FTC/TAF) én gang dagligt hos behandlingsnaïve voksne deltagere, der lever med 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.

Studieoversigt

Status

Rekruttering

Betingelser

Human Immundefekt Virus Type 1 (HIV-1) Infektion

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

570

Fase

Fase 2
Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Toll Free Number
Telefonnummer: 1-888-577-8839
E-mail: Trialsites@msd.com

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Phase 2: ISL + ULO Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks	Medicin: ISL ISL 2 x 1 mg oral capsules administered qw for 96 weeks Andre navne: MK-8591 islatravir Medicin: ULO ULO 2 x 100 mg oral tablets administered qw for 96 weeks Andre navne: MK-8507 ulonivirine
Aktiv komparator: Phase 2: BIC/FTC/TAF Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks	Medicin: BIC/FTC/TAF BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks Andre navne: BIKTARVY® bictegravir/emtricitabin/tenofoviralafenamid
Eksperimentel: 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	Medicin: Placebo for BIC/FTC/TAF BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks Medicin: ISL/ULO ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks Andre navne: MK-8591B
Aktiv komparator: 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	Medicin: BIC/FTC/TAF BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks Andre navne: BIKTARVY® bictegravir/emtricitabin/tenofoviralafenamid Medicin: Placebo to ISL/ULO ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: Baseline (Day 1) and Week 96	Body weight will be collected throughout the study.	Baseline (Day 1) and Week 96

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Efterforskere

Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. december 2025

Primær færdiggørelse (Anslået)

1. februar 2029

Studieafslutning (Anslået)

18. december 2031

Datoer for studieregistrering

Først indsendt

1. december 2025

Først indsendt, der opfyldte QC-kriterier

1. december 2025

Først opslået (Faktiske)

5. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

8591B-062
U1111-1323-4689 (Registry Identifier: UTN)
2025-522519-40 (Registry Identifier: EU CT)
MK-8591B-062 (Anden identifikator: MSD)
2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

En klinisk undersøgelse af Islatravir og Ulonivirine til personer med HIV-1, der ikke tidligere har fået behandling (MK-8591B-062)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Publikationer og nyttige links

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt