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(MCA-0885) Safety and pharmacokinetics of 10-1074 mAb


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A phase 1, open label, dose-escalation study of the safety, pharmacokinetics and antiretroviral activity of 10-1074 monoclonal antibody in HIV-infected and HIV-uninfected individuals

Principal Investigator:
Marina Caskey M.D.

Investigators:

Contact Information:
Recruitment Specialist
1230 York Ave
New York, NY 10065
Telephone: 1800RUCARES
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The research will test a new drug called 10-1074, which is a monoclonal antibody to HIV, the virus that causes AIDS (acquired immune deficiency syndrome). This study is the first time that this drug is being tested in human beings. An antibody is a substance that the body makes in response to an infection. A monoclonal antibody is an artificial substance made in the laboratory. Monoclonal means that the antibody is created to attach to something specific in the body. The monoclonal antibody we are testing attaches to HIV, and can block HIV from attacking cells in your body and from spreading to other parts of the body. 10-1074 is being developed to treat and potentially prevent HIV infection. In this research we will test this monoclonal antibody in people who are HIV-positive, as well as in HIV-negative individuals. The monoclonal antibody, 10-1074, being tested was designed by scientists at the Rockefeller University and was manufactured at Celldex Therapeutics Inc. One of the reasons to do this study is to find out if it is safe to give this drug. The second reason is to determine the best dose level for this drug. And the third reason is to determine how this drug might affect HIV levels in HIV-infected individuals.



Detailed Description of Protocol:




What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. HIV-infected Groups 1A-1C 1. Off ART for at least 8 weeks 2. No Chronic Hepatitis B or C 3. CD4 above 300 4. No diabetes 5. No chronic medical conditions (such as autoimmune diseases) other than HIV

Gender:
Both

Age(s):
18-64

Children permitted to participate:
No

Potential Benefits.....
No known benefit to participant



Compensation:
Compensation is provided