MK-8527 / Merck (MSD) - LARVOL DELTA

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. (PubMed, Clin Infect Dis) - P1 | "In adults living with HIV-1 who had not previously taken antiretroviral agents, single doses of MK-8527 as low as 0.5 mg achieved ≥1.0 log10 decreases in HIV-1 RNA at 7 days post-dose administration."

Journal • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

A clinical study of MK-8527 to prevent HIV-1 (MK-8527-011) (clinicaltrialsregister.eu) - P2/3 | N=100 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Hepatology

A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

Weekly Oral Prophylaxis With MK-8527 Protects Rhesus Macaques From Intrarectal Challenge With Simian-Human Immunodeficiency Virus. (PubMed, J Infect Dis) - "Prophylaxis with MK-8527 completely protected macaques from SHIV infection, supporting its further clinical development for prevention of HIV-1 acquisition."

Journal • Human Immunodeficiency Virus • Infectious Disease

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (clinicaltrials.gov) - P3 | N=4580 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (clinicaltrials.gov) - P3 | N=4390 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2027 ➔ Jul 2027 | Trial primary completion date: Oct 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics and safety of MK-8527 in adults with moderate or severe renal impairment (EACS 2025) - P1 | "Exposure of intracellular MK-8527-TP was also increased in participants with moderate or severe RI. A single 6-mg dose of MK-8527 was well tolerated in participants with moderate or severe RI."

Clinical • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

Safety and Pharmacokinetics of MK-8527 in Adults Without HIV. (PubMed, Clin Transl Sci) - "The safety and PK profiles of MK-8527 support continued clinical development. Trial Registration: EudraCT numbers: 2016-004647-36 (trial A); 2018-000846-20 (trial B)."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase translocation with potential for extended-duration dosing. (PubMed, PLoS Biol) - "MK-8527 and MK-8527-TP demonstrated favorable in vitro off-target profiles, with IC50 values of ≥95 µM against human DNA polymerases tested, and no off-target activities at 10 μM against a panel of 114 enzyme and receptor binding assays. Collectively, the potent antiretroviral activity and favorable preclinical PK and off-target profiles make MK-8527 an attractive clinical candidate, and it is currently in clinical trials for once-monthly oral HIV-1 pre-exposure prophylaxis."

Journal • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (clinicaltrials.gov) - P3 | N=4390 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (clinicaltrials.gov) - P3 | N=4580 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

Safety and pharmacokinetics of MK-8527 oral once-monthly: a phase 2 study in adults at low risk of HIV-1 exposure (IAS-HIV 2025) - P2 | "MK-8527 was well tolerated with a similar safety profile to placebo in adults at low risk of HIV-1 exposure. The pharmacokinetics of MK-8527 and MK-8527-TP support the continued development of MK-8527 oral QM for PrEP."

Clinical • Late-breaking abstract • P2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012) (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

Plans for MK-8527-07 (IAS-HIV 2025) - No abstract available

A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (clinicaltrials.gov) - P3 | N=4390 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Hepatology

A Study of MK-8527 in Healthy Adult Participants (MK-8527-013) (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Completed

Trial completion