Phase 1
Completed N=17
A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)
Human Immunodeficiency Virus Infection · AIDS Virus
Source: ClinicalTrials.gov NCT03615183 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Change From Baseline in Plasma HIV-1 RNA — -1.39; -1.66; -0.95 log10 copies/mL
Summary
This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma HIV-1 RNA |
-1.39; -1.66; -0.95 | — |
| PRIMARY Percentage of Participants Who Report 1 or More Adverse Events (AEs) |
0; 33.3; 0 | — |
| PRIMARY Percentage of Participants Who Were Discontinued From the Study Due to an AE |
0; 0; 0 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) of MK-8527-TP in Peripheral Blood Mononuclear Cells (PBMC) |
178; 64.1; 29.1 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to Last (AUC0-last) of MK-8527-TP in PBMC |
235; 108; 49.5 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-8527-TP in PBMC |
265; 146; 55.0 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-8527-TP in PBMC |
1.81; 0.644; 0.265 | — |
| SECONDARY Time to Cmax (Tmax) of MK-8527-TP in PBMC |
18.00; 24.00; 24.00 | — |
| SECONDARY Concentration at 168 Hours (C168) of MK-8527-TP in PBMC |
0.509; 0.334; 0.0978 | — |
| SECONDARY Apparent Terminal Half Life (t1/2) of MK-8527-TP in PBMC |
117.84; 188.66; 210.93 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) of MK-8527 in Plasma |
0.926; 0.152; 0.0189 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to Last (AUC0-last) of MK-8527 in Plasma |
0.880; 0.121; 0.0151 | — |
| SECONDARY Area Under the Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-8527 in Plasma |
1.10; 0.196; NA | — |
| SECONDARY Maximum Concentration (Cmax) of MK-8527 in Plasma |
0.177; 0.0371; 0.0162 | — |
| SECONDARY Time to Cmax (Tmax) of MK-8527 in Plasma |
0.50; 0.50; 0.50 | — |
| SECONDARY Concentration at 168 Hours (C168) of MK-8527 in Plasma |
NA; NA; NA | — |
| SECONDARY Apparent Terminal Half Life (t1/2) of MK-8527 in Plasma |
40.31; 12.36; NA | — |
Eligibility Criteria
Inclusion Criteria
- Other than HIV infection, is in good health
- Is documented HIV-1 positive
- Diagnosed with HIV-1 infection ≥ 3 months prior to screening or perform the French 2008 Haute Autorité de Santé (HAS) Algorithm to confirm chronic HIV.
- Is ART-naïve which is defined as having never received any antiretroviral agent or the following: ≤30 consecutive days of an investigational antiretroviral agent, excluding an Nucleoside reverse transcriptase inhibitors (NRTI), or ≤60 consecutive days of combination ART not including an NRTI
- Has not received an investigational agent or marketed ART within 30 days of study drug administration
- Is willing to receive no other ART for the monitoring period of the study
- Has a Body Mass Index (BMI) ≤35 kg/m^2, inclusive
- If the male participant has a female partner(s) of childbearing potential, he must agree to use a medically acceptable method of contraception during the study and for 120 days after the last dose of study drug. If their partner is pregnant, males must agree to use a condom and no additional method of contraception is required for the pregnant partner
- If the participant is a female with reproductive potential, she must demonstrate a serum β-human chorionic gonadotropin (β-hCG) level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the prestudy (screening) visit, throughout the study (including washout intervals between treatment periods/panels) and until 28 days after the last dose of study drug.
- If the participant is a postmenopausal female: she is without menses for at least 1 year and have a documented follicle stimulating hormone (FSH) level in the postmenopausal range at prestudy (screening)
- If the participant is a surgically sterile female: she is status posthysterectomy, or oophorectomy
Exclusion Criteria
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
- Is mentally or legally incapacitated at the time of the prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder over the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
- History of cancer (malignancy)
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
- Positive for hepatitis B surface antigen
- History of chronic hepatitis C unless there has been documented cure and/or participant with a positive serologic test for hepatitis C virus (HCV) has a negative HCV viral load (VL)
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks
- 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 drug, throughout the study, until the poststudy visit.
- Participated in another investigational study within 4 weeks
- Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving
Data sourced from ClinicalTrials.gov (NCT03615183). 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.