A Study to Assess the Long-term Efficacy (24 Weeks) of MPC-4326 in Combination With a 2-3 Drug OBR Relative to the Efficacy of a 3-4 Drug ARV Regimen in Treatment Experienced HIV-1 Infected Subjects Who Are Failing Current Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT01026727|
Recruitment Status : Terminated (For strategic buisness reasons.)
First Posted : December 4, 2009
Last Update Posted : June 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: MPC-4326 plus a 2-3 drug optimized background regimen (OBR) Drug: 3-4 commercially available antiretroviral drugs||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2b Multicenter, Randomized, Open Label, Comparative Trial of MPC-4326 in Combination With a Two to Three Drug Optimized Background Regimen Versus an Optimized, Three to Four Drug Antiretroviral Regimen for the Treatment of Triple Class Antiretroviral Experienced, HIV-1 Infected Subjects Failing Current Therapy|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Experimental: MPC-4326 plus a 2-3 drug optimized background regimen (OBR)
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)
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
Active Comparator: 3-4 drug antiretroviral drugs
3-4 commercially available antiretroviral (ARV)drugs for 24 weeks.
Drug: 3-4 commercially available antiretroviral drugs
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026727
Show 25 Study Locations
|Study Director:||Andrew Beelen, MD||Myrexis Inc.|