A Phase 1 dose-escalation study of the safety, tolerability, pharmacokinetics, and antiviral activity of the bispecific antibody 10E8.4/iMab given either intravenously (open-label) in HIV-1-infected and uninfected individuals or subcutaneously (open-label and placebo-controlled) in HIV-1-uninfected individuals (HIV)
Bispecific Antibody Study for 18-60-year-old People Who Live With HIV/AIDS
Sponsor: Aaron Diamond AIDS Research Center
Enrolling: Male and Female Patients
Study Length: 24 Days
Clinic Visits: 11
IRB Number: AAAS1239
Contact: Anyelina Cantos: 212-305-7897 / ac4314@cumc.columbia.edu
Additional Study Information: Antibodies are one of the natural ways that our bodies fight or prevent infection. Were testing an antibody to find out if its safe, if it doesn't make people feel uncomfortable and to find out what may be the best dose if its given by IV infusion or sub-cutaneous injection. You cannot get HIV from the Bispecific Antibody. We'll ask you to complete a brief online questionnaire at your leisure to find out if you meet basic study criteria. If eligible, we'll invite you to our clinic to review the study and possibly draw blood to find out if you meet medical criteria.If you're eligible and decide to participate, you'll come to our research clinic for 11 visits over 6 months. You'll receive an injection or infusion of the antibodies at 1 visit only and we'll ask you to return to the clinic another 10 times to complete follow up visits that require blood to be drawn. You will be compensated $200 for the injection or infusion visit, $50 for each of 10 visits involving blood draw only, and an additional $275 will be given to those that complete all 11 study visits as scheduled.Information learned from your participation will help end HIV by benefiting science and HIV prevention.
This study is closed
Magdalena Sobieszczyk, MD
Do You Qualify?
Do you live with HIV? Yes No
Do you weigh over 220 lbs? Yes No
Are breastfeeding, pregnant, or planning to become pregnant in the next 8 months? Yes No
Have you been in a clinical trial in the last 3 mos. or planning to join a clinical trial other than this one in the next 8 mos? Yes No
You may be eligible for this study

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For more information, please contact:
Anyelina Cantos