Phase 1
Completed N=20
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)
Human Immunodeficiency Virus
Source: ClinicalTrials.gov NCT05494736 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) — -1.38; -1.40; -0.80 HIV-1 RNA copies/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) |
-1.38; -1.40; -0.80 | — |
| PRIMARY Number of Participants Experiencing ≥1 Adverse Event (AE) |
5; 5; 2 | — |
| PRIMARY Number of Participants Discontinuing From Study Due to an AE |
0; 0; 0 | — |
| SECONDARY 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) |
29.2; 12.6; 5.53 | — |
| SECONDARY Area Under the Concentration-Time Curve From Predose to Infinity (AUC0-inf) of MK-8527-TP in PBMCs |
47.7; 24.5; 8.87 | — |
| SECONDARY Area Under the Concentration-Time Curve From Predose to Last Measurable Concentration (AUC0-last) of MK-8527-TP in PBMCs |
40.9; 17.1; 5.88 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-8527-TP in PBMCs |
0.270; 0.134; 0.0535 | — |
| SECONDARY Concentration at 168 Hours Postdose (C168) of MK-8527-TP in PBMCs |
0.111; 0.0484; 0.0224 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of MK-8527-TP in PBMCs |
24.00; 24.03; 23.91 | — |
| SECONDARY Apparent Terminal Half-life (t½) of MK-8527-TP in PBMCs |
128.24; 172.09; 80.15 | — |
| SECONDARY AUC0-inf of MK-8527 in Plasma |
0.0512; NA; NA | — |
| SECONDARY AUC0-last of MK-8527 in Plasma |
0.0304; NA; NA | — |
| SECONDARY Clast of MK-8527 in Plasma |
0.00388; 0.00433; 0.00417 | — |
| SECONDARY Cmax of MK-8527 in Plasma |
0.0224; 0.00935; 0.00469 | — |
| SECONDARY Tmax of MK-8527 in Plasma |
0.50; 0.50; 0.50 | — |
| SECONDARY Apparent t½ of MK-8527 in Plasma |
3.25; NA; NA | — |
| SECONDARY Correlation Between Intracellular C168 of MK-8527-TP in PBMCs and Change From Baseline in Plasma HIV-1 RNA |
NA; NA; NA; -0.342 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05494736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.