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MK-8527

DRUG12 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

AIDS VirusHIVHIV Pre-Exposure ProphylaxisHIV Pre-exposure ProphylaxisHealthyHealthy ParticipantsHepatic ImpairmentHuman Immunodeficiency Virus

Phase 1

A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)
CompletedNCT03615183
Merck Sharp & Dohme LLCAIDS Virus, Human Immunodeficiency Virus
Start: 2019-02-11End: 2019-09-26Updated: 2020-09-28
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)
CompletedNCT05494736
Merck Sharp & Dohme LLCHuman Immunodeficiency Virus
Start: 2022-11-17End: 2024-01-31Updated: 2025-03-26
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
CompletedNCT06295796
Merck Sharp & Dohme LLCRenal Impairment
Start: 2024-06-20End: 2025-01-31Updated: 2026-02-17
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
Active, not recruitingNCT06580587
Merck Sharp & Dohme LLCHealthy, HIV Pre-exposure Prophylaxis
Start: 2025-04-15End: 2026-03-27Target: 12Updated: 2026-02-27
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
CompletedNCT06783192
Merck Sharp & Dohme LLCHIV Pre-Exposure Prophylaxis, Human Immunodeficiency Virus (HIV)
Start: 2023-08-14End: 2023-10-11Updated: 2025-01-20
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
CompletedNCT06816043
Merck Sharp & Dohme LLCHealthy
Start: 2025-02-21End: 2025-06-17Updated: 2025-06-27
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
CompletedNCT06893081
Merck Sharp & Dohme LLCHealthy
Start: 2025-04-28End: 2025-07-17Updated: 2025-07-29
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
CompletedNCT07025551
Merck Sharp & Dohme LLCHealthy Participants, Hepatic Impairment
Start: 2025-09-19End: 2026-02-13Updated: 2026-02-27
A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
CompletedNCT07063238
Merck Sharp & Dohme LLCHealthy
Start: 2025-08-12End: 2025-12-29Updated: 2026-01-29

Phase 2

Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
CompletedNCT06045507
Merck Sharp & Dohme LLCHIV, HIV Pre-exposure Prophylaxis
Start: 2023-11-08End: 2025-02-12Updated: 2026-01-07

Phase 3

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
RecruitingNCT07044297
Merck Sharp & Dohme LLCHIV Pre-Exposure Prophylaxis, Human Immunodeficiency Virus (HIV)
Start: 2025-07-31End: 2027-07-22Target: 4390Updated: 2026-03-30
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
RecruitingNCT07071623
Merck Sharp & Dohme LLCHIV Pre-Exposure Prophylaxis, Human Immunodeficiency Virus (HIV)
Start: 2025-11-10End: 2027-10-18Target: 4580Updated: 2026-03-30

Related Papers

Antiretroviral Activity, Pharmacokinetics, and Safety of MK-8527, an Oral Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults Living With HIV-1 Who Had Not Previously Taken Antiretroviral Agents: Results From Two Open-Label, Phase 1 Studies.
2026-03-14