A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)

NCT ID: NCT03615183

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2019-09-26

Brief 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.

Detailed Description

Up to five panels (Panels A-E) of 6 participants each will be enrolled in a sequential manner. In each panel, participants will receive a single dose of MK-8527 up to 50 mg. Historical data from previous single does studies will be used for placebo (control) comparisons.

Conditions

Human Immunodeficiency Virus; AIDS Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel A: 10 mg MK-8527

Single oral dose of 10 mg MK-8527 capsule after an 8-hour fast

Group Type: EXPERIMENTAL

MK-8527

Intervention Type: DRUG

Single oral capsule

Panel B: 3 mg MK-8527

Single oral dose of 3 mg MK-8527 capsule after an 8-hour fast

Group Type: EXPERIMENTAL

MK-8527

Intervention Type: DRUG

Single oral capsule

Panel C: 1 mg MK-8527

Single oral dose of 1 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.

Group Type: EXPERIMENTAL

MK-8527

Intervention Type: DRUG

Single oral capsule

Panel D: ≤50 mg MK-8527

Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.

Group Type: EXPERIMENTAL

MK-8527

Intervention Type: DRUG

Single oral capsule

Panel E: ≤50 mg MK-8527

Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.

Group Type: EXPERIMENTAL

MK-8527

Intervention Type: DRUG

Single oral capsule

Interventions

MK-8527

Single oral capsule

Intervention Type: DRUG

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 approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
• Is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day
• Has a positive urine drug screen

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Matei Bals Infectious Diseases Institute ( Site 0001)

Bucharest, , Romania

Countries

Romania

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-001861-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8527-002

Identifier Type: OTHER

Identifier Source: secondary_id

8527-002

Identifier Type: -

Identifier Source: org_study_id