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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: HIV Infection

Treatments: Drug: MK-4646

Study type: Interventional

Funder types: Industry

Identifiers

NCT07042945

2025-521102-17-00 (Registry Identifier)

MK-4646-003 (Other Identifier)

4646-003

U1111-1318-7985 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

MK-4646 Panel A

Experimental group

Description:

MK-4646 160 mg every 24 hours (q24h) for 7 days

Treatment:

Drug: MK-4646

MK-4646 Panel B

Experimental group

Description:

MK-4646 ≤460 mg q24h for 7 days

Treatment:

Drug: MK-4646

MK-4646 Panel C

Experimental group

Description:

MK-4646 ≤460 mg q24h for 7 days

Treatment:

Drug: MK-4646

MK-4646 Panel D

Experimental group

Description:

MK-4646 ≤460 mg every 12 hours (q12h) for 7 days

Treatment:

Drug: MK-4646