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| ID | Type | Description | Link |
|---|---|---|---|
| BVM Study 204 |
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To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an initial treatment response will have the option to continue MPC-4326 in combination with an Optimized Backround Regimen for a maximum of 72 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPC-4326 200 mg BID X 14 Days | Experimental |
| |
| MPC-4326 300 mg BID X 14 Days. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevirimat dimeglumine | Drug | Patients will be treated with MPC-4326 200mg monotherapy for 14 days. Once the Day 15 viral load results become available, patients, who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HIV-1 viral load from baseline to day 15 | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability | 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Beelen, MD | Myrexis Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Research Initiative | Darlinghurst | New South Wales | 2010 | Australia | ||
| Holdsworth House Medical Practice |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C479935 | bevirimat |
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|
| bevirimat dimeglumine | Drug | Patients will be treated with MPC-4326, 300 mg monotherapy for 14 days. Once the Day 15 viral load results become available patients who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72. |
|
| Darlinghurst |
| New South Wales |
| 2010 |
| Australia |
| St Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Taylor Square Private Clinic | Darlinghurst | New South Wales | 2010 | Australia |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |