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)

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT05766501
Other study ID #	8591A-054
Secondary ID	MK-8591A-0542022
Status	Active, not recruiting
Phase	Phase 3
First received
Last updated
Start date	March 17, 2023
Est. completion date	January 14, 2026

Study information
Verified date	January 2024
Source	Merck Sharp & Dohme LLC
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	650
Est. completion date	January 14, 2026
Est. primary completion date	January 14, 2026
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

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

Sponsors *(1)*
Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States, Argentina, Australia, Canada, Chile, Colombia, Israel, Japan, New Zealand, Puerto Rico, Russian Federation, South Africa, Switzerland, Taiwan, United Kingdom,

Outcome
Type	Measure	Description	Time frame
Primary	Percentage of Participants with One or More Adverse Event (AE)	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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.	Up to 102 Weeks
Primary	Percentage of participants who Discontinue Study Intervention Due to an AE	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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.	Up to 96 Weeks
Secondary	Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) =50 copies/mL at Week 96	The percentage of participants with HIV-1 RNA =50 copies/mL at Week 96 will be reported.	Week 96
Secondary	Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96	The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.	Week 96
Secondary	Percentage of Participants with HIV-1 RNA =200 copies/mL at Week 96	The percentage of participants with HIV-1 RNA =200 copies/mL at Week 96 will be reported	Week 96
Secondary	Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions	Viral drug resistance is defined as participants with HIV-1 RNA =400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.	Up to Week 96

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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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

Outcome

External Links