DOR/ISL i HIV-1 antiretroviral behandling-naive deltagere (MK-8591A-053)
22. september 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3, randomiseret, aktivt kontrolleret, dobbeltblindt klinisk studie til evaluering af den antiretrovirale aktivitet, sikkerhed og tolerabilitet af Doravirin/Islatravir (DOR/ISL 100 mg/0,25 mg) én gang dagligt i HIV-1-inficeret behandling-naive Deltagere
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
537
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Buenos Aires, Argentina, C1405CKC
- Fundación IDEAA ( Site 5851)
-
Córdoba, Argentina, X5000JJS
- Instituto Oulton ( Site 5853)
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentina, C1427CEA
- Fundación Huésped ( Site 5850)
-
Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, S2000PBJ
- Instituto CAICI SRL ( Site 5852)
-
-
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital ( Site 5753)
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
-
Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre ( Site 5751)
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4P 0W5
- Regina General Hospital ( Site 5754)
-
-
-
-
Araucania
-
Temuco, Araucania, Chile, 4781151
- Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
-
-
Maule Region
-
Talca, Maule Region, Chile, 3465584
- Clinica Universidad Catolica del Maule ( Site 5954)
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chile, 7500710
- Biomedica Research Group-Infectology ( Site 5951)
-
Santiago, Region M. de Santiago, Chile, 7770086
- Espacio Eme ( Site 5952)
-
Santiago, Region M. de Santiago, Chile, 8330034
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
-
Santiago, Region M. de Santiago, Chile, 8380420
- Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
-
-
-
-
Atlántico
-
Barranquilla, Atlántico, Colombia, 08001
- Ciensalud Ips S A S ( Site 6050)
-
Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 6055)
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., Colombia, 110231
- Hospital Universitario San Ignacio-Infectious ( Site 6053)
-
Bogotá, Bogota D.C., Colombia, 111321
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 6052)
-
-
-
-
Bristol, City of
-
Bristol, Bristol, City of, Det Forenede Kongerige, BS10 5NB
- Southmead Hospital ( Site 7952)
-
-
England
-
London, England, Det Forenede Kongerige, E1 1BB
- Royal London Hospital ( Site 7951)
-
Manchester, England, Det Forenede Kongerige, M13 0FH
- The Hathersage Centre ( Site 7953)
-
-
London, City of
-
London, London, City of, Det Forenede Kongerige, SE5 9RL
- King's College Hospital ( Site 7950)
-
London, London, City of, Det Forenede Kongerige, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
-
-
-
-
Santo Domingo Province
-
Santo Domingo de Guzman, Santo Domingo Province, Dominikanske republik, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
-
-
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85015
- Pueblo Family Physicians ( Site 5674)
-
-
California
-
Beverly Hills, California, Forenede Stater, 90211
- Pacific Oaks Medical Group ( Site 5681)
-
Los Angeles, California, Forenede Stater, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80246
- Vivent Health ( Site 5694)
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20017
- Washington Health Institute ( Site 5689)
-
-
Florida
-
Ft. Pierce, Florida, Forenede Stater, 34982
- Midway Immunology and Research Center ( Site 5657)
-
Miami, Florida, Forenede Stater, 33133
- AHF The Kinder Medical Group ( Site 5672)
-
Miami Beach, Florida, Forenede Stater, 33140
- AHF South Beach ( Site 5663)
-
Orlando, Florida, Forenede Stater, 32803
- Orlando Immunology Center ( Site 5654)
-
Sarasota, Florida, Forenede Stater, 34237
- CAN Community Health - Sarasota ( Site 5668)
-
West Palm Beach, Florida, Forenede Stater, 33407
- Triple O Research Institute, P.A ( Site 5666)
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
-
Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
-
Atlanta, Georgia, Forenede Stater, 30309
- Atlanta I.D. Group ( Site 5680)
-
Decatur, Georgia, Forenede Stater, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
-
Macon, Georgia, Forenede Stater, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
-
Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
-
Chicago, Illinois, Forenede Stater, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
-
-
Michigan
-
Berkley, Michigan, Forenede Stater, 48072
- Be Well Medical Center ( Site 5650)
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital ( Site 5667)
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Jubilee Clinical Research ( Site 5679)
-
Las Vegas, Nevada, Forenede Stater, 89106
- Las Vegas Research Center ( Site 5691)
-
-
New Jersey
-
Hillsborough, New Jersey, Forenede Stater, 08844
- ID Care ( Site 5676)
-
Newark, New Jersey, Forenede Stater, 07102
- Saint Michael's Medical Center ( Site 5682)
-
-
New York
-
New York, New York, Forenede Stater, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
-
The Bronx, New York, Forenede Stater, 10461
- Jacobi Medical Center ( Site 5683)
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
-
Greensboro, North Carolina, Forenede Stater, 27401
- Regional Center for Infectious Diseases ( Site 5687)
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
-
-
Texas
-
Austin, Texas, Forenede Stater, 78705
- Central Texas Clinical Research ( Site 5661)
-
Bellaire, Texas, Forenede Stater, 77401
- St Hope Foundation ( Site 5659)
-
Dallas, Texas, Forenede Stater, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
-
Dallas, Texas, Forenede Stater, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
-
El Paso, Texas, Forenede Stater, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
-
Fort Worth, Texas, Forenede Stater, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
-
Longview, Texas, Forenede Stater, 75605
- DCOL Center for Clinical Research ( Site 5664)
-
-
-
-
-
Paris, Frankrig, 75018
- Hôpital Bichat - Claude-Bernard ( Site 6162)
-
Paris, Frankrig, 75571
- Hôpital Saint Antoine ( Site 6158)
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Frankrig, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
-
-
Nord
-
Tourcoing, Nord, Frankrig, 59200
- Tourcoing Hospital ( Site 6150)
-
-
Île-de-France Region
-
Bobigny, Île-de-France Region, Frankrig, 93000
- Hôpital Avicenne ( Site 6160)
-
Paris, Île-de-France Region, Frankrig, 75010
- Hôpital Saint-Louis ( Site 6159)
-
Paris, Île-de-France Region, Frankrig, 75013
- Pitie Salpetriere University Hospital ( Site 6156)
-
-
-
-
-
Guatemala City, Guatemala, 01001
- CLINIPHARM ( Site 8352)
-
Guatemala City, Guatemala, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
-
Guatemala City, Guatemala, 01010
- CELAN,S.A ( Site 8351)
-
-
-
-
-
Haifa, Israel, 3109601
- Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
-
Jerusalem, Israel, 9120
- Hadassah Medical Center-Infecious Disease ( Site 6752)
-
Ramat Gan, Israel, 5262100
- Sheba Medical Center-HIV unit ( Site 6753)
-
Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 6754)
-
-
-
-
-
Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital ( Site 6952)
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 460-0001
- National Hospital Organization Nagoya Medical Center ( Site 6953)
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital ( Site 6954)
-
Shinjyuku-ku, Tokyo, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
-
-
-
-
-
Kisumu, Kenya, 40100
- KEMRI-CMR-RCTP ( Site 8650)
-
-
Nairobi City
-
Nairobi, Nairobi City, Kenya, 00200
- CCR KEMRI (Center for Clinical Research) ( Site 8652)
-
Nairobi, Nairobi City, Kenya, 00202
- PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
-
-
-
-
-
Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur ( Site 7773)
-
-
Kedah
-
Alor Star, Kedah, Malaysia, 05460
- Hospital Sultanah Bahiyah ( Site 7776)
-
-
Kuala Lumpur
-
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Malaysia, 10450
- Hospital Pulau Pinang ( Site 7779)
-
-
Sarawak
-
Kuching, Sarawak, Malaysia, 93586
- Sarawak General Hospital ( Site 7772)
-
-
Selangor
-
Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang ( Site 7770)
-
Sungai Buloh, Selangor, Malaysia, 47000
- Hospital Sungai Buloh ( Site 7778)
-
-
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
-
-
-
-
-
Ponce, Puerto Rico, 00716
- Ponce Medical School Foundation Inc. ( Site 7452)
-
San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico ( Site 7450)
-
San Juan, Puerto Rico, 00909
- HOPE Clinical Research ( Site 7451)
-
-
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Schweiz, 4031
- University Hospital Basel-Infectiology ( Site 8151)
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Schweiz, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
-
-
-
-
-
Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
-
Madrid, Spanien, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
-
Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz ( Site 6354)
-
Málaga, Spanien, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
-
-
Alicante
-
Elche, Alicante, Spanien, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
-
L'Hospitalet de Llobregat,Barcelona, Catalonia, Spanien, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spanien, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
-
Madrid, Madrid, Comunidad de, Spanien, 28034
- Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
-
-
-
-
Free State
-
Bloemfontein, Free State, Sydafrika, 9301
- Josha Research ( Site 6652)
-
-
Gauteng
-
Johannesburg, Gauteng, Sydafrika, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
-
Johannesburg, Gauteng, Sydafrika, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
-
Johannesburg, Gauteng, Sydafrika, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sydafrika, 4052
- Wentworth Hospital ( Site 6653)
-
Ladysmith, KwaZulu-Natal, Sydafrika, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
-
Pietermaritzburg, KwaZulu-Natal, Sydafrika, 3201
- Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
-
-
North West
-
Brits, North West, Sydafrika, 0250
- Madibeng Centre for Research ( Site 6660)
-
-
Western Cape
-
Cape Town, Western Cape, Sydafrika, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
-
Cape Town, Western Cape, Sydafrika, 7925
- Desmond Tutu Health Foundation ( Site 6651)
-
Paarl, Western Cape, Sydafrika, 7626
- Be Part Yoluntu Centre ( Site 6650)
-
-
-
-
-
Chiang Mai, Thailand, 50200
- Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10330
- HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
-
Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
-
-
Ankara
-
Altindağ, Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 7650)
-
-
-
-
-
Hamburg, Tyskland, 20146
- ICH Study Center GmbH & Co. KG ( Site 6259)
-
Hamburg, Tyskland, 20246
- Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
-
-
Bavaria
-
München, Bavaria, Tyskland, 80336
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
-
-
Brandenburg
-
Freiburg, Brandenburg, Tyskland, 79106
- Universitaetsklinikum Freiburg ( Site 6256)
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Universitätsklinikum Bonn-Immunologie ( Site 6250)
-
-
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
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
- Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
- If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Exclusion Criteria:
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
- Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
- 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 cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
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 |
Intervention / Behandling |
|---|---|
|
Eksperimentel: DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks. |
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Andre navne:
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
|
Aktiv komparator: BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks. |
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth. Placebo tablet matched to DOR/ISL tablet taken by mouth. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Tidsramme: Week 48
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
Tidsramme: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 48
Tidsramme: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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 with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144
Tidsramme: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
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 with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
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 with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144
Tidsramme: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
Tidsramme: Baseline (Day 1) and Week 48
|
CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel. |
Baseline (Day 1) and Week 48
|
|
Change from baseline in CD4+ T-cells at Week 96
Tidsramme: Baseline (Day 1) and Week 96
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 96
|
|
Change from baseline in CD4+ T-cells at Week 144
Tidsramme: Baseline (Day 1) and Week 144
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 144
|
|
Incidence of viral drug resistance
Tidsramme: Up to 96 weeks
|
Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study. |
Up to 96 weeks
|
|
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
|
|
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
|
|
Change from baseline in body weight at Week 144
Tidsramme: Baseline (Day 1) and Week 144
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 144
|
|
Percentage of participants experiencing ≥1 AE through Week 144
Tidsramme: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 144
Tidsramme: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
8. marts 2023
Primær færdiggørelse (Faktiske)
13. oktober 2025
Studieafslutning (Anslået)
5. august 2029
Datoer for studieregistrering
Først indsendt
20. januar 2023
Først indsendt, der opfyldte QC-kriterier
20. januar 2023
Først opslået (Faktiske)
30. januar 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 8591A-053
- 2022-502099-22-00 (Registry Identifier: EU CT)
- jRCT2031220720 (Registry Identifier: jRCT)
- U1111-1283-2516 (Registry Identifier: UTN)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
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 .