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(MMA-0465) An Observational Study of Treated and Untreated Acute and Early HIV-1
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An Observational Study of Treated and Untreated Acute and Early HIV-1 (MMA-0465)
Principal Investigator:
Martin H. Markowitz M.D.
Investigators:
Contact Information:
Principal Investigator:
Martin H. Markowitz M.D.
Investigators:
Contact Information:
Don Garmon
Aaron Diamond AIDS Research Center
Rockefeller University
1230 York Avenue
New York, NY 10021
Aaron Diamond AIDS Research Center
Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 212-327-7290
Email: dgarmon@adarc.org
Email: dgarmon@adarc.org
Enrollment Status:
Open to Enrollment
Brief Summary of Protocol:
This is an observational study for people who are newly infected with HIV infection. In this study you can choose to receive treatment or not.
We are asking you to take part in this research study because either (1) you have just been diagnosed as having acute or primary HIV-1 infection based on the pattern of your HIV-1 antibody test and your viral load (Group A), or (2) you have been diagnosed with acute or primary HIV-1 infection in the past and have participated in a study of treatment of acute HIV infection at The Rockefeller University Hospital and are now considering changing medications (Group B).
Detailed Description of Protocol:
You will be seen in the outpatient clinic and the study doctor and/or his associates will discuss the eligibility criteria for this study and answer any questions that you may have related to these criteria. There will be a review of your medical history and all current medications that you may be taking, measurement of your weight and height, blood pressure, pulse, and respirations; physical examination; blood samples will be drawn for routine laboratory tests which include:
a complete blood cell count [CBC],
chemistries,
liver function tests,
a test for syphilis,
a test for Hepatitis B + C,
a pregnancy test (for all women of childbearing potential), HIV-1 antibody and resistance testing,
a CD4+ cell count
an HIV RNA (amount of virus in your blood, also called ‘viral load’) assessment.
At all study visits, plasma and cells will be obtained from the blood drawn. They will be stored for additional virologic and immunologic tests. Your study doctor will explain the nature and purpose of these special virologic and immunologic tests.
All participants will be asked to return to the outpatient clinic weekly for the first two weeks, at week four and monthly thereafter. Profile:
A male or female age 16 or older and are willing and able to provide written informed consent
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
Are newly infected with HIV (within 12 months).
We will provide HIV antibody and HIV Viral Load testing for patients who have symptoms consistent with new HIV infection but are undiagnosed.
All other referrals should have a documented negative HIV test within 12 months.
Gender:
Both
Age(s):
16 years and older
Children permitted to participate:
Yes
Potential Benefits.....
Your participation in the study will allow researchers to collect valuable information on the natural history of treated and untreated subjects with acute and early HIV-1 infection. Information will also be gained about how various antiretroviral drug combinations work in people infected with the HIV-1 virus. This information may be of value to you and other people with HIV disease.
If you decide to take part in this study, you will receive blood tests, CD4+ cell counts and viral load measurements at no cost to you while you are taking part in this research study. If you decide to start or change antiretroviral medications but do not have the means to obtain them (private insurance, the AIDS Drug Assistance Program [ADAP], etc.), you will be given a supply of antiretroviral medications until your drug coverage plan is available.
You may not receive any benefit from this study.
Benefits of Initiation of Anti-HIV Medications during Acute and Early HIV-1 Infection:
·The virus may be more homogeneous, and suppressing the amount of virus in your blood may be easier to achieve and maintain
·Delay or prevention of immune system compromise
·Possible decrease in the dissemination of the virus throughout your body
·Possible decrease in the formation of “hidden” cells that are infected and that are not reached by anti-HIV medication
Compensation:
There is no cost to you for being in this research study. There will be no costs to you for clinic visits or tests that are part of this study. If you have a third-party paye r (e.g. insurance, ADAP), it would be responsible for the costs of your antiretroviral medications. If you do not have the means to obtain the antiretroviral medications, you will be given a supply of these medications until your drug coverage plan is available. If you should require child-care services in order to make your clinic appointments, you will receive up to twenty- five dollars ($25) toward the amount on the receipt you submit to the study nurse for those child-care services.
Open to Enrollment
Brief Summary of Protocol:
This is an observational study for people who are newly infected with HIV infection. In this study you can choose to receive treatment or not.
We are asking you to take part in this research study because either (1) you have just been diagnosed as having acute or primary HIV-1 infection based on the pattern of your HIV-1 antibody test and your viral load (Group A), or (2) you have been diagnosed with acute or primary HIV-1 infection in the past and have participated in a study of treatment of acute HIV infection at The Rockefeller University Hospital and are now considering changing medications (Group B).
Detailed Description of Protocol:
You will be seen in the outpatient clinic and the study doctor and/or his associates will discuss the eligibility criteria for this study and answer any questions that you may have related to these criteria. There will be a review of your medical history and all current medications that you may be taking, measurement of your weight and height, blood pressure, pulse, and respirations; physical examination; blood samples will be drawn for routine laboratory tests which include:
a complete blood cell count [CBC],
chemistries,
liver function tests,
a test for syphilis,
a test for Hepatitis B + C,
a pregnancy test (for all women of childbearing potential), HIV-1 antibody and resistance testing,
a CD4+ cell count
an HIV RNA (amount of virus in your blood, also called ‘viral load’) assessment.
At all study visits, plasma and cells will be obtained from the blood drawn. They will be stored for additional virologic and immunologic tests. Your study doctor will explain the nature and purpose of these special virologic and immunologic tests.
All participants will be asked to return to the outpatient clinic weekly for the first two weeks, at week four and monthly thereafter. Profile:
A male or female age 16 or older and are willing and able to provide written informed consent
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
Are newly infected with HIV (within 12 months).
We will provide HIV antibody and HIV Viral Load testing for patients who have symptoms consistent with new HIV infection but are undiagnosed.
All other referrals should have a documented negative HIV test within 12 months.
Gender:
Both
Age(s):
16 years and older
Children permitted to participate:
Yes
Potential Benefits.....
Your participation in the study will allow researchers to collect valuable information on the natural history of treated and untreated subjects with acute and early HIV-1 infection. Information will also be gained about how various antiretroviral drug combinations work in people infected with the HIV-1 virus. This information may be of value to you and other people with HIV disease.
If you decide to take part in this study, you will receive blood tests, CD4+ cell counts and viral load measurements at no cost to you while you are taking part in this research study. If you decide to start or change antiretroviral medications but do not have the means to obtain them (private insurance, the AIDS Drug Assistance Program [ADAP], etc.), you will be given a supply of antiretroviral medications until your drug coverage plan is available.
You may not receive any benefit from this study.
Benefits of Initiation of Anti-HIV Medications during Acute and Early HIV-1 Infection:
·The virus may be more homogeneous, and suppressing the amount of virus in your blood may be easier to achieve and maintain
·Delay or prevention of immune system compromise
·Possible decrease in the dissemination of the virus throughout your body
·Possible decrease in the formation of “hidden” cells that are infected and that are not reached by anti-HIV medication
Compensation:
There is no cost to you for being in this research study. There will be no costs to you for clinic visits or tests that are part of this study. If you have a third-party paye r (e.g. insurance, ADAP), it would be responsible for the costs of your antiretroviral medications. If you do not have the means to obtain the antiretroviral medications, you will be given a supply of these medications until your drug coverage plan is available. If you should require child-care services in order to make your clinic appointments, you will receive up to twenty- five dollars ($25) toward the amount on the receipt you submit to the study nurse for those child-care services.
