New HIV drug shows promise in early trial to lower virus levels
NCT ID NCT07042945
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new experimental drug, MK-4646, in people with HIV who have never taken HIV medications. The main goals are to see if the drug is safe and tolerable, and how much it can lower the amount of HIV in the blood. About 28 participants will receive the drug and be monitored closely. This is an early-stage trial to gather initial safety and effectiveness data.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ARENSIA Exploratory Medicine ( Site 0001)
Bucharest, Bucharest, 021105, Romania
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PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)
Chisinau, 2025, Moldova
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Other studies related to the condition(s) this trial covers.
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