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

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

Recruiting
18-60 years
All
Phase 1

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Overview

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

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

Study details
    HIV Infection

NCT07042945

Merck Sharp & Dohme LLC

14 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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