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)
Phase 3 – large-scale trial before approval
Conditions:
HIV Infection
Sponsor: Merck Sharp & Dohme LLC
trial.available_in:
БГ
Overview
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.
Who can participate
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-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-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.
Locations
15
Argentina (1)
Instituto Oulton ( Site 1004)
Córdoba , Córdoba Province
Australia (1)
Holdsworth House Medical Practice ( Site 1100)
Darlinghurst , New South Wales
Canada (1)
Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
Hamilton , Ontario
Chile (1)
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
Temuco , Araucania
Colombia (1)
Hospital Universitario San Ignacio-Infectious ( Site 1501)
Bogotá , Bogota D.C.
Israel (1)
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
Haifa
Japan (1)
National Hospital Organization Nagoya Medical Center ( Site 2103)
Nagoya , Aichi-ken
New Zealand (1)
Christchurch Hospital-Infectious Diseases ( Site 2200)
Christchurch , Canterbury
Puerto Rico (1)
Clinical Research Puerto Rico ( Site 2400)
San Juan
Russia (1)
Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
Kemerovo , Kemerovo Oblast
South Africa (1)
Josha Research ( Site 2603)
Bloemfontein , Free State
Switzerland (1)
University Hospital Basel-Infectiology ( Site 2802)
Basel , Canton of Basel-City
Taiwan (1)
Kaohsiung Veterans General Hospital ( Site 2901)
Kaohsiung City
United Kingdom (1)
University Hospitals Sussex NHS Foundation Trust ( Site 3004)
East Sussex , Brighton And Hove
United States (1)
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)