A5370: Anti-PD-1 Antibody in HIV-1

ACTG A5370: Anti-PD-1 Antibody (Cemiplimab) in Persons Living with HIV (PLWH) on Suppressive cART

Treatment Category: Treatment-experienced

Study Description
HIV Researchers are looking for ways to effectively clear the HIV that stays in the body despite successful anti-HIV treatment. Anti-PD-1 is a type of antibody that may improve the immune system’s ability to target cells infected with HIV. This study will include PLWH whose viral loads are suppressed on their current anti-HIV medications. Participants will receive two doses of an anti-PD-1 antibody, called cemiplimab, or placebo.

Study Status: Open

Why is this study being done?

  • To find out if cemiplimab is safe and effective at targeting the latent cells infected with HIV
  • To evaluate changes in immune cells

Who can join?

People with HIV who:

  • Are 18 to 64 years old
  • Have “undetectable” HIV viral load on stable anti-HIV medications
  • Do not have a recent history of cancer, HIV-related opportunistic infections, diabetes, active hepatitis C or hepatitis B, or autoimmune disease.

What do I need to do in the study?

  • Participants will receive two doses of cemiplimab or placebo, given intravenously (IV) through a vein in the arm at the beginning and at week 6 of the study.
  • Participants will be followed for safety evaluations and to check immune function for 48 weeks.

What treatments or drugs are involved with this study?
The study treatment that will be provided through the study is cemiplimab. 

Study Status: