NCT07042945CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 9 Jun 2025
- Start date
- 9 Jul 2025
- Primary completion date
- 5 Jun 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT07042945
- EU CT number
- 2025-521102-17-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From 9 Jul 2025 to the primary completion date, 5 Jun 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse
Other
- Is an excessive smoker, or consumes excessive amounts of alcoholic or caffeinated beverages
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002) Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.