Are you a person living with HIV? Have you been taking antiretroviral drugs that have been controlling your HIV for at least two years? You may be able to participate in a research study to find out if an investigational vaccine called Trimer 4571 is safe and well tolerated in people living with HIV and if it will help the body’s immune system respond to HIV. Compensation is provided.
Antibodies called broadly neutralizing antibodies (bnAbs) help the body fight infection, but research shows that most people with HIV (human immunodeficiency virus) do not naturally develop bnAbs. bnAbs help to prevent HIV from entering healthy cells and may also help destroy HIV-infected cells.
The purpose of this research study is to find out if an investigational vaccine called Trimer 4571, which is a vaccine designed to stimulate the development of bnAbs against HIV, is safe and well tolerated in people living with HIV and will help the body’s immune system respond to HIV. Trimer 4571 is investigational, which means that it is not approved by the US Food and Drug Administration (FDA).
COULD THIS STUDY BE RIGHT FOR YOU?
- Men and women ages 18 and up
- Living with HIV
- Have been taking antiretroviral drugs to control your HIV for at least two years
- CD4+ is 200 or more
- Not pregnant or breastfeeding (must be on birth control if there is reproductive potential)
- No chronic inflammatory conditions
WHAT PARTICIPANTS CAN EXPECT
Study participation involves 11 study visits over about 50 weeks. Eligible participants will be randomly assigned (like the flip of a coin) to receive either the Trimer 4571 vaccine or a placebo vaccine. A placebo is a solution that does not have the Trimer 4571 vaccine. Participants will receive three doses of the assigned study vaccine: one at entry, one at week eight, and one at week 20. After week 20, participants will be followed for 24 additional weeks with study visits and tests to monitor health and safety and to learn how the study vaccine affects the immune system and the virus.
IRB:STUDY21020201 - sIRB Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) vaccine, in HIV-1 Infected Adults on suppressive ART - DAIDS-ES 38763 Version 2.0
MEET THE RESEARCHER
Madhu Choudhary is an Associate Professor in the Division of Infectious Diseases in the Department of Medicine at the University of Pittsburgh. A graduate of Maulana Azad Medical College, Dr. Choudhary’s research interests include HIV and viral hepatitis therapeutic clinical trials.