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(MMA-0776) Immune Activation HIV Positive IDU


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Correlates and Consequences of Increased Immune Activation in HIV-1 Infected Injection Drug Users

Principal Investigator:
Martin H. Markowitz M.D.

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

Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7280
Email: mlamar@adarc.org
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
The goal of this study is to learn how injecting drugs may affect the immune system of people who are infected with HIV-1. It is thought that activating the immune system by injection drug use may increase destruction of immune cells and interfere with recovery of the immune system when HIV treatment is given. To understand this we will sample your immune system in the blood and in the gastrointestinal tissue. To test this theory, we are enrolling three groups of people:

1) HIV-positive injection drug users who are not taking HIV medications
2) HIV-positive people who do not inject drugs and who are not taking HIV medications
3) HIV-positive people who do not inject drugs and who have taken medications to treat their HIV for at least 12 months.

The reason for doing this research is to determine how injecting drugs can affect the response to HIV treatments in HIV-positive people.



Detailed Description of Protocol:
If you join the research study, you will take part for 14 days to 13 months, depending on your group assignment. The research study as a whole will last about 5 years. About 180 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. Some participants 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.

Group 1 participants will discuss starting antiretroviral therapy with their study doctor. Particpants will return once a month for 13 months for follow up.



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

Participants must fall into one of the 3 groups:

1) HIV-positive injection drug users who are not taking HIV medications
2) HIV-positive people who do not inject drugs and who are not taking HIV medications
3) HIV-positive people who do not inject drugs and who have taken medications to treat their HIV for at least 12 months

Gender:
Both

Age(s):
18-55

Children permitted to participate:
No

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.



Compensation:
Compensation is provided.