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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

MK-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, București, Romania