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(MMA-0610) Randomized Trial of Open-Label Truvada with Atazanavir/ritonavir versus Multi-class Therapy
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A Phase II, Randomized Trial of Open-Label Truvada with Atazanavir/ritonavir versus Multi-class Therapy with Truvada, Atazanavir/ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (MMA-0610)
Principal Investigator:
Martin H. Markowitz M.D.
Investigators:
Contact Information:
Principal Investigator:
Martin H. Markowitz M.D.
Investigators:
Contact Information:
Don Garmon
The Rockefeller University
1230 York Avenue
New York, NY 10021
The Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 212-327-7290
Email: dgarmon@adarc.org
Email: dgarmon@adarc.org
Enrollment Status:
Closed to Enrollment
Brief Summary of Protocol:
The reason for conducting this research is to see if antiretroviral (ARV) medications that target HIV at 4 different steps in the viral life cycle better prevents HIV from making copies of itself when compared to a standard three-drug treatment commonly used to treat HIV infection that targets 2 different steps in the viral life cycle.
Detailed Description of Protocol:
If you decide to join this study, you will be put in one of two groups.
Group #1
-Will receive a combination of 5 drugs.
Group #2
-Will get standard HIV therapy which consists of 3 drugs.
You have a 2 out of 3 chance of being in the group that receives 5 drugs. Profile:
If you join the research study, you will take part for between 60 and 96 weeks.
The research study as a whole will last about 96 weeks.
About 36 people will take part in the research study.
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
• You have just been diagnosed as having acute (recent) HIV-1 infection.
• You have not taken any ARV medications for more than 7 days at any time prior to study entry.
Gender:
Both
Age(s):
18 years and older
Children permitted to participate:
No
Potential Benefits.....
• You may find out during the research study that the medications are helpful to you.
• You may benefit from what we learn in this research study whether the medications help you or not.
• You will receive free monitoring and if randomized to the multiclass arm, you will also receive free medications (raltegravir and maraviroc).
Compensation:
There is no cost to you for being in this research study.
You will not be paid for participation in this research study.
Closed to Enrollment
Brief Summary of Protocol:
The reason for conducting this research is to see if antiretroviral (ARV) medications that target HIV at 4 different steps in the viral life cycle better prevents HIV from making copies of itself when compared to a standard three-drug treatment commonly used to treat HIV infection that targets 2 different steps in the viral life cycle.
Detailed Description of Protocol:
If you decide to join this study, you will be put in one of two groups.
Group #1
-Will receive a combination of 5 drugs.
Group #2
-Will get standard HIV therapy which consists of 3 drugs.
You have a 2 out of 3 chance of being in the group that receives 5 drugs. Profile:
If you join the research study, you will take part for between 60 and 96 weeks.
The research study as a whole will last about 96 weeks.
About 36 people will take part in the research study.
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
• You have just been diagnosed as having acute (recent) HIV-1 infection.
• You have not taken any ARV medications for more than 7 days at any time prior to study entry.
Gender:
Both
Age(s):
18 years and older
Children permitted to participate:
No
Potential Benefits.....
• You may find out during the research study that the medications are helpful to you.
• You may benefit from what we learn in this research study whether the medications help you or not.
• You will receive free monitoring and if randomized to the multiclass arm, you will also receive free medications (raltegravir and maraviroc).
Compensation:
There is no cost to you for being in this research study.
You will not be paid for participation in this research study.
