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(MCA-0835) Open label study for monoclonal antibody in HIV-infected and HIV-uninfected volunteers


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A phase 1, open label, dose-escalation study of the safety, pharmacokinetics and antiretroviral activity of 3BNC117 monoclonal antibody in HIV-infected and HIV-uninfected volunteers

Principal Investigator:
Marina Caskey M.D.

Investigators:

Contact Information:
Recruitment Specialist
1230 York Ave
New York, Ne 10065
Telephone: 18007822737
Alt. Telephone: 18007822737
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The research will test a drug called 3BNC117, which is a monoclonal antibody to HIV, the virus the causes AIDS (acquired immune deficiency syndrome). This study is the first time that this drug is being tested in human beings. A monoclonal antibody is an artificial substance made in the laboratory. An antibody is a substance that the body makes in response to an infection. 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. 3BNC117 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.



Detailed Description of Protocol:




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

1. HIV-infected individuals 2. On or off therapy 3. No history of hepatitis B or C 4. No participation in another clinical study of an investigation product 5. Cannot be pregnant

Gender:
Both

Age(s):
18-65

Children permitted to participate:
No

Potential Benefits.....
You are unlikely to have any direct benefits from participating in this study. It is possible that the 3BNC117 will lead to better control of HIV infection, and it may improve the treatment of patients with HIV in the future.



Compensation:
Compensation is provided