A Phase 2 interventional study of MPC-4326 plus a 2-3 drug optimized background regimen (OBR) and 3-4 commercially available antiretroviral drugs in HIV Infections, sponsored by Myrexis Inc.. Terminated at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-14.
Sponsored by Myrexis Inc. · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 2 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Myrexis Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects with the following laboratory parameters within 14 days prior to first dose of study drug:
MPC-4326 300 mg or 400mg BID plus a 2-3 drug optimized background regimen (OBR)for 24 weeks.
Drug: MPC-4326 plus a 2-3 drug optimized background regimen (OBR)
3-4 commercially available antiretroviral (ARV)drugs for 24 weeks.
Drug: 3-4 commercially available antiretroviral drugs
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.
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
This study is terminated, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Myrexis Inc.