islatravir (MK-8591) / Merck (MSD) 
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12 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
islatravir (MK-8591) / Merck (MSD)
Impower-022, NCT04644029 / 2021-001289-39: Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

Terminated
3
730
US, RoW
Islatravir, MK-8591, Placebo to FTC/TDF, FTC/TDF, TRUVADA™, Emtricitabine/Tenofovir disoproxil, Emtricitabine/Tenofovir disoproxil fumarate, Placebo to ISL
Merck Sharp & Dohme LLC
HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
07/23
06/24
Impower-024, NCT04652700 / 2020-003309-79: Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)

Terminated
3
494
Europe, Japan, US, RoW
ISL, MK-8591, FTC/TDF, Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate, FTC/TAF, Descovy, Emtricitabine/Tenofovir Alafenamide, Placebo to ISL, Placebo to FTC/TDF, Placebo to FTC/TAF
Merck Sharp & Dohme LLC
HIV Preexposure Prophylaxis
08/23
08/23
ISLEND-2, NCT06630299: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

Recruiting
3
600
Europe, Japan, US, RoW
ISL/LEN, Antiretroviral Combinations
Gilead Sciences
HIV-1-Infection
06/27
08/30
ISLEND-1, NCT06630286: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

Recruiting
3
600
Europe, Canada, Japan, US, RoW
ISL/LEN, B/F/TAF, Biktarvy®, PTM B/F/TAF, PTM ISL/LEN
Gilead Sciences
HIV-1-infection
06/26
08/30
NCT04003103: Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)

Completed
2a
242
US, RoW
Islatravir, MK-8591, Placebo
Merck Sharp & Dohme LLC
HIV-1 Infection
03/22
11/22
2020-003071-18: Dose Ranging, Switch Study of ISL and MK-8507 Once-Weekly

Not yet recruiting
2
140
Europe
Islatravir, MK-8507, MK-8591, MK-8507, Capsule, Tablet, Film-coated tablet, Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
HIV-1 infection, HIV-1 infection, Diseases [C] - Virus Diseases [C02]
 
 
2017-000437-32: Dose Ranging Trial of MK-8591 Given in Combination with Doravirine (DOR) and Lamivudine (3TC)

Not yet recruiting
2
120
Europe
MK-8591, Doravirine, Doravirine/Lamivudine/Tenofovir disoproxil fumarate, Epivir, MK-8591A, MK-8591, MK-1439, MK-1439A, MK-8591A, Capsule, Film-coated tablet, Epivir
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
HIV-1 infection, HIV-1 infection, Diseases [C] - Virus Diseases [C02]
 
 
MK-8591-013, NCT04564547: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) []

Completed
2
161
Europe, US
Islatravir, MK-8591, Ulonivirine, MK-8507, BIC/FTC/TAF, BIKTARVY®, Placebo to ISL, Placebo to Ulonivirine, Placebo to BIC/FTC/TAF
Merck Sharp & Dohme LLC
HIV-1 Infection
01/25
01/25
NCT05052996: Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Active, not recruiting
2
142
US
ISL, LEN, GS-6207, B/F/TAF, Biktarvy®
Gilead Sciences, Merck Sharp & Dohme LLC
HIV-1 Infection
12/23
11/27
MK-8591-043, NCT05115838: Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Withdrawn
2
175
NA
Islatravir, MK-8591, Placebo
Merck Sharp & Dohme LLC
Human Immunodeficiency Virus, HIV
10/25
10/25
MK-8507-016, NCT06619678: A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants

Completed
1
36
US
MK-8507, Islatravir, ISL, MK-8591
Merck Sharp & Dohme LLC
Healthy
06/24
06/24
NCT06811246: A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)

Completed
1
20
US
Islatravir (ISL), MK-8591, ISL, Lamivudine (3TC), 3TC
Merck Sharp & Dohme LLC
Healthy
07/24
07/24

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