HIV-1 Infection Clinical Trial
Official title:
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | November 1, 2026 |
| Est. primary completion date | October 19, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundación IDEAA ( Site 5851) | Buenos Aires | |
| Argentina | Fundación Huésped ( Site 5850) | Caba | Buenos Aires |
| Argentina | Instituto Oulton ( Site 5853) | Cordoba | |
| Argentina | Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854) | Mar del Plata | Buenos Aires |
| Argentina | Instituto CAICI SRL ( Site 5852) | Rosario | Santa Fe |
| Canada | Clinique Medicale lActuel ( Site 5752) | Montréal | Quebec |
| Chile | Biomedica Research Group-Infectology ( Site 5951) | Santiago | Region M. De Santiago |
| Chile | Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953) | Santiago | Region M. De Santiago |
| Chile | Espacio Eme ( Site 5952) | Santiago | Region M. De Santiago |
| Chile | Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950) | Santiago | Region M. De Santiago |
| Chile | Clinica Universidad Catolica del Maule ( Site 5954) | Talca | Maule |
| Chile | Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955) | Temuco | Araucania |
| Colombia | Ciensalud Ips S A S ( Site 6050) | Barranquilla | Atlantico |
| Colombia | Clinica de la Costa S.A.S. ( Site 6055) | Barranquilla | Atlantico |
| Colombia | Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051) | Bogota | Distrito Capital De Bogota |
| Colombia | Hospital Universitario San Ignacio-Infectious ( Site 6053) | Bogota | Distrito Capital De Bogota |
| Colombia | Fundación Valle del Lili ( Site 6052) | Cali | Valle Del Cauca |
| Dominican Republic | Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250) | Santo Domingo De Guzman | Santo Domingo |
| France | Hôpital Avicenne ( Site 6160) | Bobigny | Ile-de-France |
| France | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153) | Nice | Alpes-Maritimes |
| France | Hôpital Bichat - Claude-Bernard ( Site 6162) | Paris | |
| France | Hôpital Saint Antoine ( Site 6158) | Paris | |
| France | Hôpital Saint-Louis ( Site 6159) | Paris | Ile-de-France |
| France | Pitie Salpetriere University Hospital ( Site 6156) | Paris | Ile-de-France |
| France | Tourcoing Hospital ( Site 6150) | Tourcoing | Nord |
| Germany | Universitätsklinikum Bonn-Immunologie ( Site 6250) | Bonn | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Freiburg ( Site 6256) | Freiburg | Baden-Wurttemberg |
| Germany | ICH Study Center GmbH & Co. KG ( Site 6259) | Hamburg | |
| Germany | Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260) | Hamburg | |
| Germany | Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio | München | Bayern |
| Guatemala | CELAN,S.A ( Site 8351) | Guatemala | |
| Guatemala | Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350) | Guatemala | |
| Guatemala | CLINIPHARM ( Site 8352) | Guatemala | |
| Israel | Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751) | Haifa | |
| Israel | Hadassah Medical Center-Infecious Disease ( Site 6752) | Jerusalem | |
| Israel | Sheba Medical Center-HIV unit ( Site 6753) | Ramat Gan | |
| Israel | Sourasky Medical Center ( Site 6754) | Tel Aviv | |
| Japan | National Hospital Organization Nagoya Medical Center ( Site 6953) | Nagoya | Aichi |
| Japan | National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69 | Osaka | |
| Japan | Tokyo Medical University Hospital ( Site 6954) | Shinjuku-ku | Tokyo |
| Japan | Center Hospital of the National Center for Global Health and Medicine ( Site 6951) | Shinjyuku-ku | Tokyo |
| Malaysia | Hospital Sultanah Bahiyah ( Site 7776) | Alor Setar | Kedah |
| Malaysia | Hospital Selayang ( Site 7770) | Batu Caves | Selangor |
| Malaysia | Hospital Pulau Pinang ( Site 7779) | George Town | Pulau Pinang |
| Malaysia | Hospital Kuala Lumpur ( Site 7773) | Kuala Lumpur | |
| Malaysia | Sarawak General Hospital ( Site 7772) | Kuching | Sarawak |
| Malaysia | University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777) | Lembah Pantai | Kuala Lumpur |
| Malaysia | Hospital Sungai Buloh ( Site 7778) | Sungai Buloh | Selangor |
| Puerto Rico | Ponce Medical School Foundation Inc. ( Site 7452) | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico ( Site 7450) | San Juan | |
| Puerto Rico | HOPE Clinical Research ( Site 7451) | San Juan | |
| South Africa | Josha Research ( Site 6652) | Bloemfontein | Free State |
| South Africa | Madibeng Centre for Research ( Site 6660) | Brits | North-West |
| South Africa | Desmond Tutu Health Foundation ( Site 6651) | Cape Town | Western Cape |
| South Africa | Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657) | Cape Town | Western Cape |
| South Africa | Wentworth Hospital ( Site 6653) | Durban | Kwazulu-Natal |
| South Africa | Ezintsha-Clinical Research Site ( Site 6656) | Johannesburg | Gauteng |
| South Africa | Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661) | Johannesburg | Gauteng |
| South Africa | Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654) | Johannesburg | Gauteng |
| South Africa | Qhakaza Mbokodo Research Clinic ( Site 6659) | Ladysmith | Kwazulu-Natal |
| South Africa | Be Part Yoluntu Centre ( Site 6650) | Paarl | Western Cape |
| South Africa | Human Sciences Research Council-Centre for Community Based Research ( Site 6664) | Pietermaritzburg | Kwazulu-Natal |
| Spain | Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351) | Badalona | Barcelona |
| Spain | Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352) | Barcelona | |
| Spain | Hospital General Universitario de Elche-Infectius Disease ( Site 6358) | Elche | Alicante |
| Spain | Hospital Universitari de Bellvitge ( Site 6360) | L'Hospitalet De Llobregat,Barcelona | Cataluna |
| Spain | HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario 12 de Octubre ( Site 6355) | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357) | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Virgen de la Victoria ( Site 6359) | Malaga | |
| Switzerland | University Hospital Basel-Infectiology ( Site 8151) | Basel | Basel-Stadt |
| Switzerland | Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150) | Genève | Geneve |
| Thailand | Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | HIV Netherlands Australia Thailand Research Collaboration ( Site 7851) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852 | Chiang Mai | |
| Turkey | Hacettepe Universite Hastaneleri ( Site 7650) | Altindag | Ankara |
| United Kingdom | Southmead Hospital ( Site 7952) | Bristol | Bristol, City Of |
| United Kingdom | King's College Hospital ( Site 7950) | London | London, City Of |
| United Kingdom | Royal London Hospital ( Site 7951) | London | England |
| United Kingdom | The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954) | London | London, City Of |
| United Kingdom | The Hathersage Centre ( Site 7953) | Manchester | England |
| United States | Atlanta I.D. Group ( Site 5680) | Atlanta | Georgia |
| United States | Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673) | Atlanta | Georgia |
| United States | Central Texas Clinical Research ( Site 5661) | Austin | Texas |
| United States | St Hope Foundation ( Site 5659) | Bellaire | Texas |
| United States | Be Well Medical Center ( Site 5650) | Berkley | Michigan |
| United States | Pacific Oaks Medical Group ( Site 5681) | Beverly Hills | California |
| United States | Jacobi Medical Center ( Site 5683) | Bronx | New York |
| United States | Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675) | Charlotte | North Carolina |
| United States | Howard Brown Health Center-Clinical Research ( Site 5665) | Chicago | Illinois |
| United States | Rush University Medical Center-Infectious Disease ( Site 5671) | Chicago | Illinois |
| United States | University of Illinois at Chicago-Project WISH ( Site 5685) | Chicago | Illinois |
| United States | University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662) | Cincinnati | Ohio |
| United States | North Texas Infectious Diseases Consultants, P.A ( Site 5651) | Dallas | Texas |
| United States | Prism Health North Texas, Oak Cliff Health Center ( Site 5660) | Dallas | Texas |
| United States | Metro Infectious Diseases Consultants L.L.C. ( Site 5653) | Decatur | Georgia |
| United States | Henry Ford Hospital ( Site 5667) | Detroit | Michigan |
| United States | AXCES Research - Texas - El Paso ( Site 5692) | El Paso | Texas |
| United States | Midway Immunology and Research Center ( Site 5657) | Fort Pierce | Florida |
| United States | Texas Centers for Infectious Disease Associates ( Site 5656) | Fort Worth | Texas |
| United States | Regional Center for Infectious Diseases ( Site 5687) | Greensboro | North Carolina |
| United States | ID Care ( Site 5676) | Hillsborough | New Jersey |
| United States | KC CARE Health Center-Clinical Trials ( Site 5670) | Kansas City | Missouri |
| United States | Jubilee Clinical Research ( Site 5679) | Las Vegas | Nevada |
| United States | Las Vegas Research Center ( Site 5691) | Las Vegas | Nevada |
| United States | DCOL Center for Clinical Research ( Site 5664) | Longview | Texas |
| United States | Ruane Clinical Research Group, Inc ( Site 5658) | Los Angeles | California |
| United States | Mercer University, Department of Internal Medicine ( Site 5655) | Macon | Georgia |
| United States | AHF The Kinder Medical Group ( Site 5672) | Miami | Florida |
| United States | AHF South Beach ( Site 5663) | Miami Beach | Florida |
| United States | Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688) | New York | New York |
| United States | Saint Michael's Medical Center ( Site 5682) | Newark | New Jersey |
| United States | Orlando Immunology Center ( Site 5654) | Orlando | Florida |
| United States | Pueblo Family Physicians ( Site 5674) | Phoenix | Arizona |
| United States | CAN Community Health - Sarasota ( Site 5668) | Sarasota | Florida |
| United States | Washington Health Institute ( Site 5689) | Washington | District of Columbia |
| United States | Triple O Research Institute, P.A ( Site 5666) | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Canada, Chile, Colombia, Dominican Republic, France, Germany, Guatemala, Israel, Japan, Malaysia, Puerto Rico, South Africa, Spain, Switzerland, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at 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 | |
| Primary | Percentage of participants experiencing =1 adverse event (AE) through Week 48 | 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 | |
| Primary | Percentage of participants discontinuing from study treatment due to an AE through Week 48 | 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 | |
| Secondary | Percentage of participants with HIV-1 RNA <50 copies/mL at 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 | |
| Secondary | Percentage of participants with HIV-1 RNA <200 copies/mL at 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 | |
| Secondary | Percentage of participants with HIV-1 RNA <200 copies/mL at 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 | |
| Secondary | Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at 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 | |
| Secondary | Change from baseline in CD4+ T-cells at Week 96 | CD4+ T-cells are quantified with a TBNK panel. | Baseline (Day 1) and Week 96 | |
| Secondary | Incidence of viral drug resistance | 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 | |
| Secondary | Change from baseline in body weight at Week 48 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 48 | |
| Secondary | Change from baseline in body weight at Week 96 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 96 | |
| Secondary | Percentage of participants experiencing =1 AE through Week 96 | 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 96 weeks | |
| Secondary | Percentage of participants discontinuing from study treatment due to an AE through Week 96 | 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 96 weeks |
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