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(MMA-0927) A Phase III, randomized, multicenter, parallel-group, non-inferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long-acting rilpivirine from current INI-NNRTI-, or PI-based


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A Phase III, randomized, multicenter, parallel-group, non-inferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long-acting rilpivirine from current INI-NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:

Contact Information:
Recruitment Specialist
1230 York Avenue
New York , NY 10065
Telephone: 1800RUCARES
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The reason for doing this research is to compare two drugs (called Cabotegravir and Rilpivirine, as oral tablets followed by long-acting injections) to current regimens containing 3 HIV drugs. Researchers want to find out if two investigational drugs called long-acting cabotegravir (CAB LA) and long-acting rilpivirine (RPV LA) can help people with HIV compared to current available HIV medicine. The two drug regimen of CAB LA and RPV LA is considered experimental and is not yet approved to treat patients with HIV. About 570 men and women in up to 13 countries will take part in this study. New patients will no longer be put into the study once the target number has been reached.



Detailed Description of Protocol:




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

• At least 18 years of age
• On HIV treatment for at least 1 year
• Virally suppressed for at least 6 months
• Willing to consider injectable treatment


Gender:
Both

Age(s):
At least 18

Children permitted to participate:
No

Potential Benefits.....
You will not receive any direct medical benefit from taking part in this study. The potential benefit to society may be information gained on the safety and effectiveness of the study drug for patients in the future.



Compensation:
Compensation is provided