A5386, a clinical trial to control HIV in a new way


A5386: Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control in the Reservoirs During Analytic Treatment Interruption


Researchers are looking for ways to get rid of HIV that rests hidden in areas of the body (reservoirs) where current anti-HIV medicines can’t reach. This trial looks at the safety and tolerability of three new experimental drugs and whether these drugs can help a person control HIV without anti-HIV medicines.

Study Products:

IL-15 superagonist (N-803), a new experimental drug, appears to reactivate HIV that is “asleep” and is also thought to increase the body’s natural immune response to HIV. N-803 is given by a small needle under the skin, similar to a shot of insulin.

Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body’s immune response to HIV. The hope is that these antibodies could attack the cells of the body that contain the reactivated HIV. These antibodies are given through an infusion, also known as an “IV.”


Major requirements for entering the study:

  • Living with HIV, 18–70 years old.
  • Have a low or undetectable viral load for at least 2 years.
  • Agree to use contraception/birth control methods.
  • Be willing to temporarily stop taking anti-HIV medicines.

Events or conditions that would prevent participation:

  • Recent serious illness or condition requiring hospitalization.
  • Breastfeeding or pregnant.
  • Active Hepatitis B or C infection or history of AIDS-defining conditions.
  • Current CD4 cell count less than 500 or ever had a CD4 cell count less than 200.

Duration of Study:

Participants will be in this study for about 24 months.

Compensation Provided

NIH study page: clinicaltrials.gov/ct2/show/NCT04340596

Click here for A5386 participant summary July2021