This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a 3-4 antiretroviral (ARV) regimen in treatment experienced, HIV-1 infected subjects.
Standard antiretroviral therapies for the treatment of HIV/AIDS, while effective for varying lengths of time, can be rendered inadequate for viral suppression by the emergence of drug resistant virus, which can include resistance to entire mechanistic classes of drugs. Thus, there exists a significant unmet medical need for new highly potent antiretroviral agents with novel mechanisms of action. The novel mechanism of action of MPC-4326 suggests that MPC-4326 may have utility for the treatment of HIV-1 infected patients failing current regimens due to the development of drug resistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
For treatment arm #1: the MPC-4326 dose will be selected based on the inclusion of raltegravir (i.e., will be limited to 300 mg BID) or inclusion of darunavir (i.e., will be assigned 400 mg BID) in the OBR. If both raltegravir and darunavir are included in the OBR for a subject, the subject will be limited to 300 mg BID
For treatment arm #2: the antiretroviral regimen, dosage and frequency will be selected by the investigator.
AIDS Healthcare Foundation Research Center
Proportion of subjects with a viral load <50 copies/mL at 24 weeks in each treatment group
Time frame: 24-weeks
The key secondary endpoint is to compare the Viral Load Decrease at 24 weeks in the two treatment arms. VLD is defined as the change from baseline log10 viral load.
Time frame: 24 weeks
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Beverly Hills, California, United States
Peter Wolfe, MD, PC
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Gary J. Richmond, MD, PA
Fort Lauderdale, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
...and 15 more locations