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(MCA-0994) 3BNC117-LS plus 10-1074-LS in viremic individuals

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An open label, single arm study of the safety, pharmacokinetics and antiretroviral activity of the combination of 3BNC117-LS and 10-1074-LS in viremic HIV-infected individuals.

Principal Investigator:
Marina Caskey M.D.


Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1.800.RUCARES
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
The purpose of this research study is to test the effect of a single dose of two antibodies on the amount of HIV (viral load) in the blood. HIV is the virus that causes AIDS. This study will also evaluate if the study antibodies cause side effects and measure the time it takes for the antibodies to clear from the body. The antibodies we are testing in this study, 3BNC117- LS and 10-1074-LS, are antibodies were made in the laboratory. An antibody is a substance that the body makes in response to an infection. These antibodies attach to HIV and can block HIV from attaching to cells and spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV infection.

The study procedures will include the consent process where you will learn about the study and decide if you would like to participate; receiving one dose of the two study antibodies as intravenous (IV) infusions; returning to the Rockefeller University Hospital about 13 times for follow up and blood collection (3 to 8 tablespoonfuls each time); and one eye exam. The study will also include studies of the expression of your genes.

Detailed Description of Protocol:

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

- If you are at least 18 years of age
- If you have a confirmed HIV diagnosis
- If you have been off HIV treatment for at least 8 weeks



Children permitted to participate:

Potential Benefits.....
There will be no direct benefit to you. At this point, we do not know if 10-1074-LS and/or 3BNC117-LS can control HIV like standard ART medications. However, these study drugs may improve the treatment of patients with HIV in the future.

Compensation is provided.