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(MMA-0591) HIV Elite Controller Study


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HIV Elite Controller Study (MMA-0591)

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:
Martin H. Markowitz M.D.

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

Brief Summary of Protocol:
The focus of the studies to be conducted under this protocol and consent form is on the detailed analysis of host cellular and humoral immune responses, comprehensive human genome analysis and genomic analysis of the infecting viruses isolated from persons that control HIV infection.



Detailed Description of Protocol:
Current HIV vaccine strategies are based on the assumption that persistent immune control will be possible, but the extent to which this occurs in natural infection is not known. Although most persons experience progressive disease once infected with HIV, some persons maintain viral loads below the limits of detection without the need for antiviral medications.

The HIV Controller Consortium proposes to perform detailed host genetic factors associated with spontaneous control of viremia in the small subset ofpersons who are able to achieve this state without antiviral therapy. Through a nationwide collaborative effort with academic institutions and primary care physicians, we have established a cohort of 180 persons that we call "HIV controllers", namely persons who maintain viral loads of less than 2000 copies/ml despite never having been treated with antiviral therapy. 78 of these persons have maintained viral loads of less than 50 copies/ml plasma, which we term "elite controllers".

Our initial studies indicate that these controllers are a heterogeneous group with respect to immunologic, viral and host factors that are known or suspected to influence viremia, suggesting that there are multiple means to maintain low viral loads. Recent advances in the knowledge of the human genome allow us to uncover the genetic basis of such an extraordinary outcome, revealing the responsible molecular mechanisms that will lead to potential treatments.

The recruitment of up to 1000 elite controllers will provide a unique opportunity to determine the extent to which persistent control is possible in HIV infection, and the extent to which host genetic factors contribute to long-term control of viremia. Moreover, longitudinal follow up of these individuals will provide us with the opportunity to determine the factors associated with loss of control of viremia in those that will experience late increases in viremia and progressive decline in viral load.

The goal of this study is to gain a better understanding of the spontaneous control of HIV replication, the effect of cytotoxic T lymphocytes (CTL), neutralizing and binding antibodies and genetic host factors that affect the progression of HIV. Understanding the reasons that these individuals are able to maintain such control is a critical issue, since the first generation of an AIDS vaccine would be considered a success if it were able to create such a state of control following exposure to HIV.

This study involves investigators at the Partners AIDS Research Center, investigators/collaborators who belong to an HIV Controllers Consortium, The Broad Institute at MIT, and the Scripps Research Institute. Dr. Mary Carrington's Laboratory at the NIH will perform the HLA typing.

ELITE CONTROLLERS are defined as:

• Longitudinal HIV RNA that includes a minimum of 3 determinations, in the absence of antiretrovirals, which span at least a 12-month period.

• Undetectable HIV RNA levels without antiretroviral therapy.

• Episodes of viremia up to 1000 copies /mL as long as there are no consecutive viremia episodes and such episodes represent the minority of all available determinations.

Profile:
• HIV positive adults between the ages of 18-75.

• HIV positive and Hepatitis C positive adults between the ages of 18-75.

• HIV positive and Hepatitis B positive adults between the ages of 18-75.

• HIV-infected individuals with asymptomatic HIV infection.

• Pregnant females may also be included; blood amounts will not exceed 50 ml over an eight-week period of time.





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

• HIV positive adults between the ages of 18-75.

• HIV positive and Hepatitis C positive adults between the ages of 18-75.

• HIV positive and Hepatitis B positive adults between the ages of 18-75.

• HIV-infected individuals with asymptomatic HIV infection.

• Pregnant females may also be included; blood amounts will not exceed 50 ml over an eight-week period of time.

Gender:
Both

Age(s):
18-75 years of age

Children permitted to participate:
No

Potential Benefits.....
There are no direct benefits to subjects from participation in this study. It is possible that results from the study may eventually help improve the immune response to HIV infection; however, there is no guarantee.



Compensation:
$25 / visit. For additional information, please visit: http://www.mgh.harvard.edu/aids/hiv_elite_controllers.asp