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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A: MK-8527 1.0 mg

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

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

MK-8527 capsule taken by mouth.

Panel B: MK-8527 0.5 mg

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

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

MK-8527 capsule taken by mouth.

Panel C: MK-8527 0.25 mg

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

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

MK-8527 capsule taken by mouth.

Interventions

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MK-8527

MK-8527 capsule taken by mouth.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No