On the Tuesday right after our Memorial Day weekend, we will hold our next community meeting.

It’ll be held on the 2nd Floor of the West Clinic at Harborview Medical Center, down the hall from Madison Clinic.

We’ll provide dinner for you. We can cover parking in the Harborview View Park Garage. Bus tickets are also available.

And you can RSVP for this meeting by replying here on this event page.

Our topic on Tuesday night will be “first-in-human” research studies, and we will use as an example for our discussion an upcoming HIV remission study of a tri-specific broadly neutralizing antibody.

This genetically engineered “three-in-one” antibody has NIH researchers excited because it has shown in the lab tests the highest activity and breadth of coverage yet seen against HIV.

Natural antibodies recognize a single target on a foreign protein. These new antibodies were engineered to recognize 3 different target sites in one molecule.

As you know, scientists are working towards a new goal in HIV research.

Timothy Ray Brown’s apparent cure, together with other cases in which people living with HIV remained virus-free for lengthy periods, suggest that it may be possible to develop interventions that cure or, alternatively, produce long-term antiretroviral-free remission.

First-in-human (FIH) trials are one step in exploring this possibility.

Many such trials are under way and many more will be proposed in the coming years. Researchers conducting early human trials are investigating a variety of strategies, including intensified drug regimens, potential therapeutic vaccines, immunotherapy, broadly neutralizing antibodies, gene transfer agents and stem cell transplantation.

This coming Tuesday, we will be discussing our upcoming FIH trial—the Triple Antibody Study.

This study is the first in-human ascending dose study of SAR441236, a tri-specific broadly neutralizing antibody, in participants with HIV.

The study will enroll two groups of participants: HIV+ individuals currently on an antiretroviral regimen with an undetectable HIV viral load, and people with HIV who have never received anti-HIV medications.

How do we protect both sets of people in this study?

How do we help people understand the potential benefits and risks of participating in an FIH research study?

What ethical principles and regulatory rules do we follow?

Join us on Tuesday the 28th to find out more!