MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-… (NCT07042945) | Clinical Trial Compass
RecruitingPhase 1
MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
Moldova, Romania28 participantsStarted 2025-07-09
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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)…
What they're measuring
1
Participants with averse events (AEs)
Timeframe: 14 days post last dose (Up to Day 23)
2
Participants who discontinued study medication due to an AE
Timeframe: Up to Day 7
3
Viral load decline of plasma HIV-1 ribonucleic acid (RNA)