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(MMA-0639) Acute HIV-1 Infection Prospective Cohort Study

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Acute HIV-1 Infection Prospective Cohort Study, Version 2.0 (CHAVI 001)

Principal Investigator:

Martin H. Markowitz M.D.

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

Brief Summary of Protocol:
Rockefeller University is part of a group of scientists from all over the world doing research on how HIV works in the body. It is hoped that this research will help to make medicines to prevent the spread of HIV. HIV is the virus that causes AIDS. The purpose of this research study is to understand how people’s infection fighting (immune) system reacts to HIV. Your body is made-up of the cells, proteins, and other chemicals that help to fight infection. We want to know how the body, including blood and other fluids from the body, works if someone has or comes into contact with HIV. We also want to examine the genes in your body, called DNA, since they might affect how your body responds to HIV. For instance, a person that is very tall probably has different genes than a person who is very short, or a person whose ancestors come from a certain place probably have different genes compared to the genes of a person from a far off land. No two persons in the world have exactly the same genes. That is what makes each of us different. We will also be looking at your genes to study your body’s reaction to infections, including how genes turn on or off. Understanding these “genetic” differences may help us understand how the human body responds to HIV. Eligible participants will be placed into one of the following four study groups:
Group 1: Proven acute (recent) HIV-1 infection: approximately 500 total
Group 1A: Sexual partners of members of Group 1: approximately 400 total
Group 2: Established HIV-1 infection: approximately 350 total
Group 3: HIV-1 negative: approximately 50 total
We will only enroll volunteers for Group 1 at The Rockefeller University Hospital.

Detailed Description of Protocol:

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

• You are a man or woman aged 16 years or older at the time of screening.
• You are able and willing to provide adequate information for locator purposes.
• You may have certain laboratory results allowing you to be included in the study.
• You are willing to receive HIV test results.
• You are not intending to relocate out of the area for the duration of study participation and you do not have a job or other obligations that may require long absences from the area.
• You have acute (recent) HIV infection.



Children permitted to participate:

Potential Benefits.....
There may be no direct benefit to you from this study. However, you and others could benefit in the future from research done in this study, because we will learn more about HIV. The information we learn may help researchers understand better how to make vaccines or medicines to prevent or treat diseases like HIV. Knowing early in the course of infection that you have HIV may help you to prevent passing the infection to others. You will also get physical exams, information about your health, and the opportunity to talk to counselors about your health, your feelings, and ways to prevent spreading HIV. If these exams show that you have a health problem, we will treat you to the extent possible, or we will tell you where you can go for treatment. You will also receive free condoms throughout the entire course of the study.