Clinical trial NCT05766501: A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
Official title: A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.


Eligibility criteria: Inclusion Criteria:

* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).

Exclusion Criteria:

* Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Primary outcomes:
measure: Percentage of Participants with One or More Adverse Event (AE)
timeFrame: Up to 102 Weeks
measure: Percentage of participants who Discontinue Study Intervention Due to an AE
timeFrame: Up to 96 Weeks
Secondary outcomes:
measure: Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
state: Alabama
city: Phoenix
country: United States
facility: Pueblo Family Physicians ( Site 3102)
state: Arizona
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group ( Site 3123)
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente ( Site 3124)
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group, Inc ( Site 3126)
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research ( Site 3114)
state: California
city: Sacramento
country: United States
facility: University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 3130)
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center ( Site 3110)
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center ( Site 3117)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 3133)
state: Florida
city: Miami
country: United States
facility: AHF The Kinder Medical Group ( Site 3108)
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center ( Site 3106)
state: Florida
city: Orlando
country: United States
facility: Bliss Healthcare Services ( Site 3115)
state: Florida
city: Sarasota
country: United States
facility: CAN Community Health - Sarasota ( Site 3118)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A ( Site 3116)
state: Florida
city: Augusta
country: United States
facility: Augusta University-Infectious Diseases ( Site 3135)
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta ( Site 3128)
state: Georgia
city: Macon
country: United States
facility: Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
state: Georgia
city: Savannah
country: United States
facility: Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
state: Georgia
city: Kansas City
country: United States
facility: KC CARE Health Center ( Site 3103)
state: Missouri
city: Hillsborough
country: United States
facility: ID Care ( Site 3131)
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
state: New York
city: Philadelphia
country: United States
facility: Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
state: Pennsylvania
city: Bellaire
country: United States
facility: St Hope Foundation ( Site 3121)
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A ( Site 3100)
state: Texas
city: Fort Worth
country: United States
facility: Texas Centers for Infectious Disease Associates ( Site 3111)
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center ( Site 3101)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 3119)
state: Texas
city: Seattle
country: United States
facility: Private Practice - Dr. Peter Shalit ( Site 3120)
state: Washington
city: Spokane
country: United States
facility: Multicare Institute for Research and Innovation ( Site 3127)
state: Washington
city: Córdoba
country: Argentina
facility: Instituto Oulton ( Site 1004)
state: Cordoba
city: Rosario
country: Argentina
facility: Instituto CAICI SRL ( Site 1003)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Helios Salud ( Site 1002)
city: Buenos Aires
country: Argentina
facility: Fundación Huésped ( Site 1001)
city: Buenos Aires
country: Argentina
facility: Fundación IDEAA ( Site 1005)
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice ( Site 1100)
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital-IBAC ( Site 1103)
state: New South Wales
city: Brisbane
country: Australia
facility: Holdsworth House Medical Practice - Brisbane ( Site 1101)
state: Queensland
city: Melbourne
country: Australia
facility: Prahran Market Clinic ( Site 1102)
state: Victoria
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research ( Site 1301)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital ( Site 1300)
state: Ontario
city: Montreal
country: Canada
facility: Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
state: Quebec
city: Montréal
country: Canada
facility: Clinique Medicale lActuel ( Site 1303)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 1306)
state: Quebec
city: Temuco
country: Chile
facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
state: Araucania
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 1405)
state: Maule
city: Santiago
country: Chile
facility: Biomedica Research Group-Infectology ( Site 1401)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1407)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Cardio Sur ( Site 1409)
state: Region M. De Santiago
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502)
state: Distrito Capital De Bogota
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio-Infectious ( Site 1501)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 1500)
state: Valle Del Cauca
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Infecious Disease ( Site 1902)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-HIV unit ( Site 1903)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1904)
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 2103)
state: Aichi
city: Bunkyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 2105)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital ( Site 2104)
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
state: Tokyo
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
city: Christchurch
country: New Zealand
facility: Christchurch Hospital-Infectious Diseases ( Site 2200)
state: Canterbury
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico ( Site 2400)
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research ( Site 2401)
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
state: Kemerovskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
state: Krasnoyarskiy Kray
city: Saint Petersburg
country: Russian Federation
facility: Republican Clinical Infectious Hospital ( Site 2500)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
state: Moskva
city: Moscow
country: Russian Federation
facility: Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
state: Tatarstan, Respublika
city: Bloemfontein
country: South Africa
facility: Josha Research ( Site 2603)
state: Free State
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Ezintsha-Clinical Research Site ( Site 2607)
state: Gauteng
city: Pretoria
country: South Africa
facility: Private Practice Dr. Marleen de Jager ( Site 2600)
state: Gauteng
city: Durban
country: South Africa
facility: Wentworth Hospital ( Site 2604)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
state: Western Cape
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation ( Site 2602)
state: Western Cape
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 2601)
state: Western Cape
city: Basel
country: Switzerland
facility: University Hospital Basel-Infectiology ( Site 2802)
state: Basel-Stadt
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
state: Geneve
city: st.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen ( Site 2801)
state: Sankt Gallen
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
state: Ticino
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich ( Site 2800)
state: Zurich
city: Berne
country: Switzerland
facility: Inselspital Bern-Inselspital Infektiologie ( Site 2803)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 2901)
city: East Sussex
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust ( Site 3004)
state: Brighton And Hove
city: Bristol
country: United Kingdom
facility: Southmead Hospital ( Site 3003)
state: Bristol, City Of
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 3002)
state: England
city: London
country: United Kingdom
facility: King's College Hospital ( Site 3001)
state: London, City Of
city: Crumpsall
country: United Kingdom
facility: North Manchester General Hospital ( Site 3005)
state: Manchester
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: