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Completed

NCT Number: NCT05494736

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

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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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8527

Drug

MK-8527 capsule taken by mouth.

Primary outcomes

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

    Time frame: Baseline and 168 hours postdose on Day 1

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

  2. Number of Participants Experiencing ≥1 Adverse Event (AE)

    Time frame: Up to 28 days

    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.

  3. Number of Participants Discontinuing From Study Due to an AE

    Time frame: Up to 28 days

    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.

Secondary outcomes

  1. 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)

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

    The AUC0-168 of MK-8527-TP in PBMCs is reported.

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

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

    The MK-8527-TP AUC0-inf in PBMCs is reported.

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

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

    The MK-8527-TP AUC0-last in PBMCs is reported.

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

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

    The MK-8527-TP Cmax in PBMCs is reported.

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

    Time frame: 168 hours postdose

    The C168 of MK-8527-TP in PBMCs is reported.

  6. Time to Maximum Concentration (Tmax) of MK-8527-TP in PBMCs

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

    The MK-8527-TP Tmax in PBMCs is reported.

  7. Apparent Terminal Half-life (t½) of MK-8527-TP in PBMCs

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

    The apparent t½ of MK-8527-TP in PBMCs is reported.

  8. AUC0-inf of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The AUC0-inf of MK-8527 in plasma is reported.

  9. AUC0-last of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The AUC0-last of MK-8527 in plasma is reported.

  10. Clast of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The Clast of MK-8527 in plasma is reported.

  11. Cmax of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The Cmax of MK-8527 in plasma is reported.

  12. Tmax of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The Tmax of MK-8527 in plasma is reported.

  13. Apparent t½ of MK-8527 in Plasma

    Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

    The apparent t½ of MK-8527 in plasma is reported.

  14. Correlation Between Intracellular C168 of MK-8527-TP in PBMCs and Change From Baseline in Plasma HIV-1 RNA

    Time frame: Predose and 168 hours postdose

    The correlation between between the C168 of MK-8527-TP in PBMCs and the change from baseline in plasma HIV-1 RNA levels 168 hours after dosing was calculated based on all pooled participants. All participants who complied with the protocol sufficiently to ensure that generated data will belikely to exhibit the effects of treatment, according to the underlying scientific model, are included. Participants with data below the LLOQ are excluded.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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