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

NCT05494736 | Completed Phase 1 Results FDA Drug

• 4 other identifiers: 8527-004MK-8527-0042023-503682-39U1111-1287-7295
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)

  The mean change from baseline in HIV-1 RNA counts at 168 hours after a single doses of MK-8527 is reported.

  Baseline and 168 hours postdose on Day 1

• Number of Participants Experiencing ≥1 Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to 28 days

• Number of Participants Discontinuing From Study Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to 28 days

Secondary Outcomes (14)

• Area Under the Concentration-Time Curve From Predose to 168 Hours Postdose (AUC0-168) of MK-8527 Triphosphate (MK-8527-TP) in Peripheral Blood Mononuclear Cells (PBMCs)

  Predose and 4, 12, 24, 96, 120, 144, and 168 hours postdose

• Area Under the Concentration-Time Curve From Predose to Infinity (AUC0-inf) of MK-8527-TP in PBMCs

  Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

• Area Under the Concentration-Time Curve From Predose to Last Measurable Concentration (AUC0-last) of MK-8527-TP in PBMCs

  Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

• Maximum Concentration (Cmax) of MK-8527-TP in PBMCs

  Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

• Concentration at 168 Hours Postdose (C168) of MK-8527-TP in PBMCs

  168 hours postdose

Study Arms (3)

Panel A: MK-8527 1.0 mg

EXPERIMENTAL

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

Drug: MK-8527

Panel B: MK-8527 0.5 mg

EXPERIMENTAL

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

Drug: MK-8527

Panel C: MK-8527 0.25 mg

EXPERIMENTAL

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

Drug: MK-8527

Interventions

MK-8527 DRUG

MK-8527 capsule taken by mouth.

Panel A: MK-8527 1.0 mg; Panel B: MK-8527 0.5 mg; Panel C: MK-8527 0.25 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (4)

ARENSIA Exploratory Medicine-Institutul National de Boli Infectioase Matei Bals ( Site 0004)

Bucharest, București, Romania

Location

Josha Research ( Site 0003)

Bloemfontein, Free State, 9301, South Africa

Location

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0002)

Johannesburg, Gauteng, 2092, South Africa

Location

Desmond Tutu Health Foundation ( Site 0001)

Cape Town, Western Cape, 7925, South Africa

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 10, 2022
• Study Start: November 17, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

ZA (3); RO (1)