Healthy Volunteer

ADARC, in collaboration with TaiMed Biologics Inc. and the Bill and Melinda Gates Foundation, is conducting a trial of the monoclonal antibody Ibalizumab in HIV-negative, healthy volunteers. This is the first time that Ibalizumab is being tested in healthy volunteers. Ibalizumab has been tested as a treatment in HIV-positive patients, and appears to be effective, safe, and tolerable.

Ibalizumab is a humanized monoclonal antibody, which binds to the CD4 molecule, blocking HIV’s entry into the cell. Scientists would like to know if Ibalizumab is safe for use in healthy volunteers. Ultimately, once its safety is proven, scientists will test Ibalizumab’s efficacy as a prevention tool against HIV infection.

In this study, participants will receive four weekly injections of Ibalizumab at one of three dose levels, or a placebo. Doctors will follow patients to track any possible adverse reactions, and will draw blood from participants to measure how much Ibalizumab has accumulated in their bodies.

Ibalizumab is not a vaccine. It is a man-made antibody, and does not contain any part of HIV. You CANNOT contract HIV by participating in this trial.

This study includes six trial sites in four states: AL, CA, NY and TX.

(MMA-0774)
Immune Activation HIV Negative IDU

The goal of this study is to learn how injection drug use may affect the immune system. We are enrolling HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative former injection drug users.

 

(TMB-108)
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers

The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers.