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New HIV drug shows promise in early trial to lower virus levels

NCT ID NCT07042945

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

15 people

The number who actually took part.

Started

Jul 2025

Finished

Jun 2026

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • ARENSIA Exploratory Medicine ( Site 0001)

    Bucharest, Bucharest, 021105, Romania

  • PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)

    Chisinau, 2025, Moldova

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