MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

Summary

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.

Timeline

Start

2022-11-17

Primary completion

2024-01-31

Completion

2024-01-31

Publications

• Carstens RP, Kapoor Y, Vargo RC, Bhattacharyya A, Garrett G, Cilissen C, Adedoyin A, Zang X, Denef JF, Leyssens C, Reynders T, Preotescu L, Kaplan R, Rassool M, Lombaard J, Streinu-Cercel A, Matthews RP, Stoch SA, Iwamoto M, Gillespie GL. Antiretroviral Activity, Pharmacokinetics, and Safety of MK-8527, an Oral Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults With HIV-1 Who Had Not Previously Taken Antiretroviral Agents: Results From 2 Open-Label, Phase 1 Studies. Clin Infect Dis. 2026 May 20;82(5):e984-e991. doi: 10.1093/cid/ciag135.

Drugs

Indications