Immune Modulator Anktiva Does Not Control HIV Rebound

The drug did have an effect on the viral reservoir and immune responses, suggesting it might play a role in a combination cure strategy.

Published on Mar. 10, 2026

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Most people with HIV who received the immune-modulating drug Anktiva (N-803), with or without broadly neutralizing antibodies, did not experience delayed viral rebound after stopping antiretroviral treatment, but they did show some favorable changes in immune response and the viral reservoir, according to research presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.

Why it matters

These results add to the growing evidence that a combination approach will be needed for a functional cure, or long-term remission without antiretrovirals, as current strategies to control the virus, shrink the reservoir, and boost immune response have had only modest progress.

The details

Three clinical trials—ACTG A5386, a Rockefeller University study, and the Thai RV550 study—assessed whether Anktiva, with or without broadly neutralizing antibodies (bnAbs), could delay viral rebound after antiretroviral treatment interruption and boost immune response against HIV. While the Rockefeller study showed some promising results, the other two trials did not report such encouraging findings. Anktiva did appear to have some effect on the viral reservoir and immune responses, but did not lead to sustained viral control after treatment interruption as hypothesized.

  • The studies were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.
  • The FDA approved Anktiva as a treatment for bladder cancer in 2024, and Saudi Arabia recently approved it for advanced lung cancer.

The players

Anktiva (N-803)

An interleukin 15 (IL-15) receptor 'superagonist' that activates natural killer cells and CD8 killer T cells and enhances CD4 helper T-cell activity and proliferation of memory T cells. It is currently being studied for several malignancies, often in combination with immune checkpoint inhibitors, and early research suggests it may also help the immune system fight HIV.

ACTG A5386

A Phase I clinical trial sponsored by the National Institutes of Allergy and Infectious Diseases that evaluated Anktiva, with or without broadly neutralizing antibodies, in people with chronic HIV infection.

RV550

A Phase II clinical trial sponsored by the U.S. Military HIV Research Program and conducted by the Thai Red Cross that evaluated the effect of Anktiva, in combination with antiretrovirals, on the viral reservoir in people with acute HIV infection.

Brad Jones, PhD

A researcher from Weill Cornell Medicine who presented findings from the ACTG A5386 trial.

Itzayana Miller

A PhD student at Weill Cornell who looked at T cell features associated with viral control in the ACTG A5386 trial.

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What’s next

Researchers are further investigating which factors might be associated with viral control in the two people with longer remission from the ACTG A5386 trial.

The takeaway

These findings offer further evidence that combination approaches have the best prospects for inducing long-term HIV remission that could allow people to stay off antiretrovirals for several months or longer, and Anktiva might be a component of such functional cure strategies, though other approaches like bispecific antibody-like constructs that deliver IL-15 directly to memory CD4 cells may hold even more promise.