Multiple doses of MK-4646 for adults with HIV-1
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
This trial will test whether one or more doses of MK-4646 can lower the amount of HIV-1 in the blood of adults who are ART‑naïve or not currently taking antiretroviral therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 2 sites (Chisinau and 1 other locations) |
| Trial ID | NCT07042945 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, multiple-dose interventional study of MK-4646 in adults with HIV-1 to characterize safety, tolerability, and early antiviral activity. Participants who are ART‑naïve or have been off ART for at least 60 days will receive one or more escalating doses of MK-4646 and have plasma HIV‑1 RNA measured over time. The study will monitor adverse events and laboratory safety tests alongside viral load changes, with participants avoiding other ART until at least Day 8 after dosing. Results will guide dose selection and safety planning for later-phase trials.
Who should consider this trial
Good fit: Adults with confirmed HIV-1 who are generally in good health, are ART‑naïve or have been off ART for the required period, and agree to contraceptive and study visit requirements are the intended participants.
Not a fit: People with acute (primary) HIV-1 infection, significant uncontrolled medical conditions, recent ART use, or who are pregnant or breastfeeding are unlikely to benefit from this early safety-focused study.
Why it matters
Potential benefit: If successful, MK-4646 could lower viral load and provide a new therapeutic option to help control HIV-1.
How similar studies have performed: Other antibody-based HIV approaches have produced temporary viral-load reductions in prior studies, but multiple-dose MK-4646 in this patient group remains early and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chisinau and 1 other locations
- PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002) — Chisinau, Moldova (Recruiting)
- ARENSIA Exploratory Medicine ( Site 0001) — Bucharest, Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.