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Immune-Boosting cocktail aims to free HIV patients from daily medication

NCT ID NCT04340596

Cure Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This early-stage trial tests whether an experimental immune-boosting drug called N-803, given alone or with two powerful antibodies, can help people with HIV control the virus after they stop their regular antiretroviral therapy. The study enrolls adults with well-controlled HIV who have been on stable treatment for at least two years. Participants receive the study drugs and then pause their usual HIV medications under close monitoring to see if the virus stays suppressed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an IL-15 superagonist (N-803) with or without broadly neutralizing antibodies (VRC07-523LS and 10-1074)
What this could lead to
If successful, this approach could point toward a functional cure for HIV, allowing people to stop daily antiretroviral therapy without the virus rebounding.
What could go wrong
This is an early phase 1 trial focused on safety, so the chance of achieving sustained HIV control is uncertain. The immune-boosting drug may cause significant side effects, and the virus might still rebound after treatment interruption.

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

118 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 65 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 * HIV-1 infection * On ART for at least 96 weeks prior to randomization * On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization. * CD4 cell count \>450 cells/mm\^3 within 90 days prior to randomization * CD4 cell count nadir ≥200 cells/mm\^3. * Plasma HIV-1 RNA levels of \<50 copies/mL for at least 96 weeks prior to randomization * Select laboratory results within 90 days of randomization * IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay. * QTcF interval ≤440 msec within 90 days prior to randomization. * For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 30 days prior to randomization * Cisgender women and transgender men of reproductive potential must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy. * Cisgender men and transgender women participants engaging in sexual activity that could lead to pregnancy and who are of reproductive potential must agree to use a barrier method of contraception * Willingness to abstain from sexual intercourse or use a barrier method of contraception consistently * Willingness to participate in an ATI. * Weight \>50 kg and \<115 kg. * Completion of pre-entry leukapheresis Exclusion Criteria * History of AIDS-defining illness, with the exception of recurrent pneumonia. * History of or current clinical cardiovascular disease * Current clinically significant acute or chronic medical condition * History of HIV-associated neurocognitive disease * History of an HIV-associated malignancy * ART initiated during acute HIV infection * Current receipt of ART other than NRTI and integrase inhibitor. * Resistance to one or more drugs in two or more ARV drug classes. * Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past. * History of prior immunoglobulin (IgG) therapy. * History of use of any immunomodulatory medications within 6 months prior to randomization * Participation in another clinical study of an investigational product currently or within past 12 weeks * Breastfeeding or pregnancy

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infection

Contacts and locations

Locations

  • Alabama CRS (Site ID# 31788)

    Birmingham, Alabama, 35222, United States

  • Case Clinical Research Site

    Cleveland, Ohio, 44106, United States

  • Chapel Hill CRS (Site ID: 3201)

    Chapel Hill, North Carolina, 27599, United States

  • Columbia P&S CRS

    New York, New York, 10032, United States

  • Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)

    Boston, Massachusetts, 02114, United States

  • New Jersey Medical School Clinical Research Center CRS [Site ID: 31786]

    Newark, New Jersey, 07103, United States

  • Northwestern University CRS

    Chicago, Illinois, 60611, United States

  • Penn Therapeutics, CRS (Site ID: 6201)

    Philadelphia, Pennsylvania, 19104, United States

  • UCLA CARE Center CRS

    Los Angeles, California, 90035, United States

  • UCSD Antiviral Research Center CRS (Site ID: 701)

    San Diego, California, 92103, United States

  • University of California, San Fransisco HIV/AIDS CRS

    San Francisco, California, 94110, United States

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Uptown CRS (Site ID: 7803)

    New York, New York, 10065, United States

  • Whitman-Walker Institute, Inc. CRS (Site ID: 31791)

    Washington D.C., District of Columbia, 20005, United States

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