Actively Recruiting
MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-01
28
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Other than having HIV-1, is in good health
- Is antiretroviral therapy (ART)-nafve
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)
Chisinau, Moldova, 2025
Actively Recruiting
2
ARENSIA Exploratory Medicine ( Site 0001)
Bucharest, Bucharest, Romania, 021105
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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