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(MCA-0866) 3BNC117 mAb in HIV-infected subjects on combination ART


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An Open Label, Phase 2 Study of the Safety and Antiretroviral Activity of 3BNC117 in HIV-Infected Individuals on Combination Antiretroviral Therapy

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:




Detailed Description 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). 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 HIV-positive people with well controlled HIV infection, and on combination antiretroviral therapy (HIV pills). The monoclonal antibody, 3BNC117, being tested was designed by scientists at 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 antibody. Another reason is to determine how this antibody might affect HIV levels in HIV-infected individuals who are taking HIV pills and during a brief interruption of these medications.



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

- HIV positive with a CD4 count above 500 - Do not have a history of AIDS-defining illness within 1 year prior to enrollment - Do not have a history of resistance to two or more antiretroviral drug classes; - Do not have a history of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months. - Do not have Chronic hepatitis B or hepatitis C. - Do not have a significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents. - Do not have uncontrolled hypertension

Gender:
Both

Age(s):
18-65

Children permitted to participate:
No

Potential Benefits.....
No known benefit



Compensation:
Compensation is provided