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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Human Immunodeficiency Virus

Treatments: Drug: MK-8527

Study type: Interventional

Funder types: Industry

Identifiers

NCT05494736

8527-004

2023-503682-39 (Registry Identifier)

U1111-1287-7295 (Registry Identifier)

MK-8527-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is in good health other than HIV-1 infection
• Is documented HIV-1 positive
• Is ART-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of HIV-1 infection (prior use of an ART for PrEP or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration)
• Is willing to receive no other ART for the monitoring period of this study

Exclusion criteria

• Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit
• Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Panel A: MK-8527 1.0 mg

Experimental group

Description:

Participants receive a single oral dose of MK-8527 1.0 mg.

Treatment:

Drug: MK-8527

Panel B: MK-8527 0.5 mg

Experimental group

Description:

Participants receive a single oral dose of MK-8527 0.5 mg.

Treatment:

Drug: MK-8527

Panel C: MK-8527 0.25 mg

Experimental group

Description:

Participants receive a single oral dose of MK-8527 0.25 mg.

Treatment:

Drug: MK-8527