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(MMA-0754) A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of Once-Daily Doses of Cenicriviroc or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Nave, Adult Patients


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A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Nave, Adult Patients With Only CCR5-Tropic Virus

Principal Investigator:
Martin H. Markowitz M.D.

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

Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
The Rockefeller Univeristy
New York, NY 10065
Telephone: 212-327-7280
Email: mlamar@adarc.org
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The primary purpose of this study is to evaluate how effective, how safe and how well tolerated a range of Cenicriviroc (CVC, TBR-652) doses compares to a comparator drug (Efavirenz) while receiving emtricitabine/tenofovir disoproxil fumrate (Truvada) in subjects with HIV-1. A comparator drug is an agent that the investigational drug is being compared to in this study. Participants will also take a matching placebo tablet and capsule. Placebo is an inactive substance, which may resemble an active agent but has no medical value.

This is a double-blind study, which means, neither the participant nor the study doctor, the study staff or the Sponsor will know if the participant will take Cenicriviroc (CVC, TBR-652)/placebo or Efavirenz/placebo.



Detailed Description of Protocol:
About 150 people will take part in the research study at about 50 sites in the United States and Puerto Rico. About 6 participants will be enrolled at The Rockefeller University Hospital.

Participation includes:
- 2 screening visits
- Receiving study treatment for 48 weeks
- ~14 study visits to our Outpatient Research Center over a 52 week period.



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

- Are at least 18 years of age
- Are HIV-1 infected
- Never received antiretroviral treatment


Gender:
Both

Age(s):
18+

Children permitted to participate:
No

Potential Benefits.....
You may not have any personal benefit from being in this study. This study may or may not help your condition. However, even if you do not take part in this study, your study doctor will discuss other alternatives with you. The information gained during this study may help doctors learn more about treating HIV-1 infected patients. This knowledge may help patients in the future.



Compensation:
Compensation is provided.