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
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