RecruitingPhase 1NCT07042945

MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)

Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1

Sponsor

Merck Sharp & Dohme LLC

Enrollment

28 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Infection

Summary

This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount. The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria7

Other than having HIV-1, is in good health
Is antiretroviral therapy (ART)-naïve
If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening
Is willing to receive no other ART prior to Day 8 post-dose of the trial
If capable of producing sperm agrees to use contraception
If assigned female sex at birth is not breastfeeding
A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum), and uses a contraceptive method that is highly effective

Exclusion Criteria11

Has acute (primary) HIV-1 infection
Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
Has history of cancer (malignancy)
Has history of significant multiple and/or severe allergies
Tests positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies
Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 14 days following study intervention
Is unable to refrain from using protocol specified prohibited medications
Is an excessive smoker, or consumes excessive amounts of alcoholic or caffeinated beverages
Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse