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| Sponsor: | Myrexis Inc. |
|---|---|
| Information provided by: | Myrexis Inc. |
| ClinicalTrials.gov Identifier: | NCT01026727 |
Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 2 |
| Study Start Date: | November 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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
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Active Comparator: 3-4 drug antiretroviral drugs
3-4 commercially available antiretroviral (ARV)drugs for 24 weeks.
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Drug: 3-4 commercially available antiretroviral drugs
For treatment arm #2: the antiretroviral regimen, dosage and frequency will be selected by the investigator.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with the following laboratory parameters within 14 days prior to first dose of study drug:
Contacts and Locations
Show 25 Study Locations| Study Director: | Andrew Beelen, MD | Myrexis Inc. |
More Information
| Responsible Party: | Andrew Beelen, MD, Myriad Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01026727 History of Changes |
| Other Study ID Numbers: | MPC-4326-003.01 |
| Study First Received: | December 2, 2009 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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HIV Infections Acquired Immunodeficiency Syndrome Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases Sexually Transmitted Diseases |
Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes HIV treatment experienced bevirimat |
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HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |