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)
- Conditions
- HIV Infection
- Interventions
- Drug: DOR/ISL
- Registration Number
- NCT05766501
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 650
- 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]).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DOR/ISL DOR/ISL Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.
- Primary Outcome Measures
Name Time Method Percentage of Participants with One or More Adverse Event (AE) Up to 102 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. 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.
Percentage of participants who Discontinue Study Intervention Due to an AE Up to 96 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. 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 will be reported.
Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 96 will be reported
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions Up to Week 96 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.
Trial Locations
- Locations (95)
Mills Clinical Research ( Site 3114)
🇺🇸Los Angeles, California, United States
Maple Leaf Research ( Site 1301)
🇨🇦Toronto, Ontario, Canada
Kaiser Permanente ( Site 3124)
🇺🇸Los Angeles, California, United States
Floridian Clinical Research, LLC ( Site 3133)
🇺🇸Miami Lakes, Florida, United States
North Texas Infectious Diseases Consultants, P.A ( Site 3100)
🇺🇸Dallas, Texas, United States
University Hospitals Sussex NHS Foundation Trust ( Site 3004)
🇬🇧East Sussex, Brighton And Hove, United Kingdom
University Hospital Basel-Infectiology ( Site 2802)
🇨🇭Basel, Basel-Stadt, Switzerland
North Manchester General Hospital ( Site 3005)
🇬🇧Crumpsall, Manchester, United Kingdom
Instituto CAICI SRL ( Site 1003)
🇦🇷Rosario, Santa Fe, Argentina
Hospital Universitario San Ignacio-Infectious ( Site 1501)
🇨🇴Bogotá, Distrito Capital De Bogota, Colombia
Cantonal Hospital St.Gallen ( Site 2801)
🇨🇭st.Gallen, Sankt Gallen, Switzerland
Be Part Yoluntu Centre ( Site 2601)
🇿🇦Paarl, Western Cape, South Africa
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
🇨🇭Lugano, Ticino, Switzerland
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Tokyo Metropolitan Komagome Hospital ( Site 2105)
🇯🇵Bunkyo, Tokyo, Japan
Georgetown University Medical Center ( Site 3130)
🇺🇸Washington, District of Columbia, United States
Pontificia Universidad Catolica de Chile ( Site 1407)
🇨🇱Santiago, Region M. De Santiago, Chile
Ruane Clinical Research Group, Inc ( Site 3126)
🇺🇸Los Angeles, California, United States
Cardio Sur ( Site 1409)
🇨🇱Santiago, Region M. De Santiago, Chile
Orlando Immunology Center ( Site 3106)
🇺🇸Orlando, Florida, United States
Holdsworth House Medical Practice - Brisbane ( Site 1101)
🇦🇺Brisbane, Queensland, Australia
Helios Salud ( Site 1002)
🇦🇷Buenos Aires, Argentina
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
🇺🇸New York, New York, United States
Infectious Disease Specialists of Atlanta ( Site 3128)
🇺🇸Decatur, Georgia, United States
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
🇨🇱Santiago, Region M. De Santiago, Chile
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
🇺🇸Philadelphia, Pennsylvania, United States
HOPE Clinical Research ( Site 2401)
🇵🇷San Juan, Puerto Rico
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
AHF The Kinder Medical Group ( Site 3108)
🇺🇸Miami, Florida, United States
Clinica Universidad Catolica del Maule ( Site 1405)
🇨🇱Talca, Maule, Chile
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
🇨🇭Genève, Geneve, Switzerland
Toronto General Hospital ( Site 1300)
🇨🇦Toronto, Ontario, Canada
Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
🇯🇵Shinjyuku-ku, Tokyo, Japan
Fundación Huésped ( Site 1001)
🇦🇷Buenos Aires, Argentina
Sheba Medical Center-HIV unit ( Site 1903)
🇮🇱Ramat Gan, Israel
Josha Research ( Site 2603)
🇿🇦Bloemfontein, Free State, South Africa
Kaohsiung Veterans General Hospital ( Site 2901)
🇨🇳Kaohsiung, Taiwan
KC CARE Health Center ( Site 3103)
🇺🇸Kansas City, Missouri, United States
Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
🇨🇦Hamilton, Ontario, Canada
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
🇮🇱Haifa, Israel
McGill University Health Centre ( Site 1306)
🇨🇦Montréal, Quebec, Canada
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
🇨🇱Temuco, Araucania, Chile
Biomedica Research Group-Infectology ( Site 1401)
🇨🇱Santiago, Region M. De Santiago, Chile
Desmond Tutu Health Foundation ( Site 2602)
🇿🇦Cape Town, Western Cape, South Africa
Tokyo Medical University Hospital ( Site 2104)
🇯🇵Shinjuku-ku, Tokyo, Japan
Sourasky Medical Center ( Site 1904)
🇮🇱Tel Aviv, Israel
Clinique Medicale lActuel ( Site 1303)
🇨🇦Montréal, Quebec, Canada
Inselspital Bern-Inselspital Infektiologie ( Site 2803)
🇨🇭Berne, Switzerland
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
🇿🇦Johannesburg, Gauteng, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
🇿🇦Cape Town, Western Cape, South Africa
Royal Free Hospital ( Site 3002)
🇬🇧London, England, United Kingdom
Fundación Valle del Lili ( Site 1500)
🇨🇴Cali, Valle Del Cauca, Colombia
Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
🇷🇺Kemerovo, Kemerovskaya Oblast, Russian Federation
Southmead Hospital ( Site 3003)
🇬🇧Bristol, Bristol, City Of, United Kingdom
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
🇯🇵Osaka, Japan
Pueblo Family Physicians ( Site 3102)
🇺🇸Phoenix, Arizona, United States
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
🇷🇺Moscow, Moskva, Russian Federation
CAN Community Health - Sarasota ( Site 3118)
🇺🇸Sarasota, Florida, United States
Therafirst Medical Center ( Site 3110)
🇺🇸Fort Lauderdale, Florida, United States
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
🇺🇸Birmingham, Alabama, United States
Augusta University-Infectious Diseases ( Site 3135)
🇺🇸Augusta, Georgia, United States
Bliss Healthcare Services ( Site 3115)
🇺🇸Orlando, Florida, United States
The Crofoot Research Center ( Site 3101)
🇺🇸Houston, Texas, United States
St Hope Foundation ( Site 3121)
🇺🇸Bellaire, Texas, 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
Holdsworth House Medical Practice ( Site 1100)
🇦🇺Darlinghurst, New South Wales, Australia
St Vincent's Hospital-IBAC ( Site 1103)
🇦🇺Sydney, New South Wales, Australia
Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
🇨🇦Montreal, Quebec, Canada
Hadassah Medical Center-Infecious Disease ( Site 1902)
🇮🇱Jerusalem, Israel
Clinical Research Puerto Rico ( Site 2400)
🇵🇷San Juan, Puerto Rico
National Hospital Organization Nagoya Medical Center ( Site 2103)
🇯🇵Nagoya, Aichi, Japan
Republican Clinical Infectious Hospital ( Site 2500)
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
🇷🇺Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
🇷🇺Moscow, Moskva, Russian Federation
UniversitätsSpital Zürich ( Site 2800)
🇨🇭Zürich, Zurich, Switzerland
Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
🇺🇸Macon, Georgia, United States
Pacific Oaks Medical Group ( Site 3123)
🇺🇸Beverly Hills, California, United States
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
🇺🇸Sacramento, California, United States
ID Care ( Site 3131)
🇺🇸Hillsborough, New Jersey, United States
Triple O Research Institute, P.A ( Site 3116)
🇺🇸West Palm Beach, Florida, United States
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
🇿🇦Johannesburg, Gauteng, South Africa
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
🇺🇸Savannah, Georgia, United States
DCOL Center for Clinical Research ( Site 3119)
🇺🇸Longview, Texas, United States
Private Practice Dr. Marleen de Jager ( Site 2600)
🇿🇦Pretoria, Gauteng, South Africa
Prahran Market Clinic ( Site 1102)
🇦🇺Melbourne, Victoria, Australia
Instituto Oulton ( Site 1004)
🇦🇷Córdoba, Cordoba, Argentina
Fundación IDEAA ( Site 1005)
🇦🇷Buenos Aires, Argentina
Christchurch Hospital-Infectious Diseases ( Site 2200)
🇳🇿Christchurch, Canterbury, New Zealand
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Ezintsha-Clinical Research Site ( Site 2607)
🇿🇦Johannesburg, Gauteng, South Africa
King's College Hospital ( Site 3001)
🇬🇧London, London, City Of, United Kingdom
Wentworth Hospital ( Site 2604)
🇿🇦Durban, Kwazulu-Natal, South Africa
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