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

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

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called MK-4646, given in multiple doses to people living with HIV-1 who are not currently on antiretroviral (HIV) treatment. The goal is to understand the drug's safety, how the body handles it over time, and how it affects HIV levels in the blood. **You may be eligible if...** - You have HIV-1 but are otherwise in good general health - You have never received antiretroviral therapy, OR you have not taken any antiretroviral drugs in the past 60 days - You are willing to temporarily stop any antiretroviral therapy during the study period - If you can produce sperm, you are willing to use contraception - If assigned female sex at birth, you are not pregnant or breastfeeding **You may NOT be eligible if...** - You are currently on antiretroviral therapy that you are not able or willing to pause - You are pregnant or breastfeeding - You have significant health conditions beyond HIV that would affect safety - Your CD4 cell count or viral load is outside the acceptable range for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-4646

MK-4646 in capsular form administered orally


Locations(2)

PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)

Chisinau, Moldova

ARENSIA Exploratory Medicine ( Site 0001)

Bucharest, Bucharest, Romania

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NCT07042945


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