NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: HIV Infection

Interventions: MK-4646

Countries: Moldova, Romania

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Chisinau, Moldova
Bucharest, Bucharest, Romania