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(MMA-0774) Immune Activation HIV Negative IDU

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Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Principal Investigator:
Martin H. Markowitz M.D.

Saurabh Mehandru M.D.
Sharon Karmon MD, MPH
Teresa Evering M.D.

Contact Information:
Melissa LaMar
Aaron Diamond AIDS Research Center
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7280
Enrollment Status:

Brief Summary of Protocol:
The goal of this study is to learn how injection drug use may affect the immune system. One way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the same time. It is thought that activating the immune system by injection drug use may increase destruction of immune cells in the gut. To test this theory, we are enrolling HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative former injection drug users.

The reason for doing this research is to determine how injecting drugs can cause activation of the immune system. This activation may affect people’s health.

Detailed Description of Protocol:
If you join the research study, you will take part for 14 days to 3 months, depending on your group assignment. The research study as a whole will last about 5 years.

About 192 people will take part in the research study.

The study involves a screening visit to determine eligibility. If you are eligible and decided to particiate you will be invited back for the study procedure called a flexible sigmoidoscopy. If you are a non-injection drug user, you will only be asked to do this procedure one time. If you are in one of the injection drug user groups (active or former), you may be asked to do this procedure twice. If you are asked to undergo this procedure twice, you will be re-screened before the 2nd sigmoidoscopy.

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

- HIV negative
- Current injection drug users OR
- Former injection drug users OR
- No history of injection drug use



Children permitted to participate:

Potential Benefits.....
The benefit for the individual subject will include a complete history, physical and laboratory examinations. If any abnormalities are found during the sigmoidoscopy procedure, we will recommend that you see your primary care provider for a full evaluation. If HIV infected, patients will be informed of their viral load and lymphocyte values and if necessary referred for care.

Compensation is provided.