HIV breakthrough? drug may let patients ditch daily meds
NCT ID NCT07145164
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
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.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 'Queen Mothers' bring HIV testing to the doorstep?
- Scientists map HIV's hiding spots in early infection
- Can local clinics keep more people with HIV in care?
- Can a phone call keep HIV-Positive mothers and babies on track?
- Can a phone app and a health worker ease depression in rural HIV care?
- Can a diabetes and Weight-Loss drug help break cocaine addiction?