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HIV breakthrough? drug may let patients ditch daily meds

NCT ID NCT07145164

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a drug called N-803 (IL-15) can train the immune system to control HIV without daily antiretroviral therapy. Twenty people with HIV on stable treatment will receive the drug or a placebo, then temporarily stop their HIV meds to see if the virus stays under control. The goal is to reduce or eliminate the need for lifelong daily pills.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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.

Key Inclusion Criteria: * Age ≥ 18 and ≤ 70 years at the time of screening * Documented HIV-1 infection * On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months * Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months * Screening CD4+ T-cell count ≥ 350 cells/mm3 * Willingness to interrupt ART as part of the study transient treatment interruption Exclusion Criteria: * On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen * Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening. * Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen * Evidence of HIV "elite" control immediately prior to ART initiation * Screening platelets \< 125,000/mm3 * Screening hemoglobin \< 12.5 g/dL for men and \<11.5 for women * History of an AIDS-defining illness according to CDC criteria * History of HIV-associated malignancy * Non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months preceding screening, or for whom such therapies are expected in the subsequent 12 months. * Active Hepatitis B (Hep B) infection (defined as Hep B surface antigen (sAg) positive or HBV DNA positive) * Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA) * Chronic liver disease * Chronic kidney disease * Active and poorly controlled atherosclerotic cardiovascular disease * QTc interval \>450msec (male) or \>470msec (female) * Pregnant, breastfeeding, or unwilling to use contraception to prevent pregnancy during participation in the study and until 6 months resumption of ART * Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) in the partner, with sexual partners not known to have HIV

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCSF

    San Francisco, California, 94044, United States

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Other studies related to the condition(s) this trial covers.