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(MMA-0781) A Phase IIb, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors


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A Phase IIb, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of HIV-1 virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK1265744 is combined with oral rilpivirine in HIV-1 infected, antiretroviral therapy naive adult subjects

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:
Saurabh Mehandru M.D.
Teresa Evering M.D.

Contact Information:
Melissa LaMar
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:
Closed to Enrollment

Brief Summary of Protocol:
Researchers want to find out if an investigational drug called GSK1265744 can help people with HIV. GSK1265744 is not approved for doctors to prescribe to patients. The purpose of this study is to test the safety of GSK1265744 and how well it works. Three different doses of GSK1265744 will be compared in order to choose the best dose. There will also be a group of patients in the study who receive Sustiva (efavirenz, EFV), which is used to treat HIV infection and is approved for doctors to prescribe to patients. You will get either GSK1265744 or Sustiva in combination with other HIV medications to treat your HIV.

This study has two separate parts. It has an “Induction” period and a “Maintenance” period. The purpose of the “Induction” period is to determine how well the treatments lower HIV in the blood. The purpose of the “Maintenance” period is to determine how well the treatments can keep HIV levels low for as long as you continue in the study.



Detailed Description of Protocol:
About 200 people in the United States will take part in this study. Approximately 5 volunteers will be enrolled by Dr. Markowitz and his associates at The Rockefeller University Hospital Outpatient Clinic. Once we have about 200 people who agree to be part of the study, we will not invite any more.

This study will last a total of 96 weeks (about 2 years) and has two separate parts. It has an “Induction” part that lasts for 24 weeks, and a “Maintenance” part that lasts for 72 weeks. If you choose to participate, you would have 19 or more visits with the study doctor or staff. During this time, you will need to get tests, visit the clinic on schedule, take your medications every day and tell us about any changes in your health or medicine. It is possible that you will not be able to continue in the study after Week 20. If you get assigned to take GSK1265744, you may be able to continue on the study longer than 96 weeks. The study could stop at any time for safety or other reasons.



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

- HIV positive
- Have not been treated for HIV OR
- Have not taken more than 10 days of medicine to treat your HIV

Gender:
Both

Age(s):
18+

Children permitted to participate:
No

Potential Benefits.....
Taking part in this study may or may not make your health/condition better. Information from this study may help doctors learn more about HIV and treatment for HIV or help identify who is more likely to benefit and who is more likely to have side effects from GSK1265744. This information may help future HIV patients.



Compensation:
Compensation is provided.