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DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

NCT05705349
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to DOR/ISL, Placebo to BIC/FTC/TAF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
537 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2029
U.S. locations
38
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 29 more
Conditions
Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
Interventions
Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, Estradiol 2mg, Placebo
Drug · Other
Lead sponsor
Thomas Jefferson University
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
24
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 19 more
Conditions
HIV-1 Infection
Interventions
Islatravir, Placebo to Islatravir, Doravirine, Placebo to Doravirine, Lamivudine, Placebo to Lamivudine, Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, Doravirine/Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
10
States / cities
Phoenix, Arizona • Sacramento, California • Washington D.C., District of Columbia + 7 more
Conditions
HIV Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to FDC DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
643 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
28
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 24 more
Conditions
HIV-1 Infection
Interventions
ISL, DOR, DOR/ISL, Placebo to ISL, Placebo to DOR
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
Not listed
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • Palm Springs, California + 15 more
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
599 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
17
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 14 more