Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase II Multicenter, Open-label, Randomized, Parallel Group, Study of Bevirimat in HIV-1 Positive Patients to Evaluate the Safety, Efficacy, and Pharmacokinetics of MPC-4326 Administered as Monotherapy for 14 Days and as Part of an Optimized Background Regimen for up to 72 Weeks.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: bevirimat dimeglumine
* Drug: bevirimat dimeglumine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age at the time of screening. Have HIV-1-infection. Have a CD4+-lymphocyte count≥100 cells/mm3 Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of 2,000 - 500,000 copies/mL (inclusive). Be free from any acute infection or serious medical illness within 14 days prior to study entry. Exclusion Criteria: Current opportunistic infection characteristic of AIDS (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version, Appendix A) that is diagnosed within 30 days or is poorly controlled. Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood pressure < 60 mmHg or > 90 mmHg. A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medications. A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA). Patients with the following laboratory parameters within 30 days prior to first dose of study drug: Hemoglobin < 10.0 g/dL for men and < 9.0 g/dL for women Neutrophil count < 1000/mm3 Platelet count < 50,000/mm3 AST or ALT > 2.5 times the upper limit of normal (patients with a positive HBV surface antigen or HCV antibody test at screening must have AST and ALT no more than 1.5 times the upper limit of normal)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPC-4326 200 mg BID X 14 Days<br> | Drug: bevirimat dimeglumine<br>* 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.<br>|
| Experimental: MPC-4326 300 mg BID X 14 Days.<br> | Drug: bevirimat dimeglumine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV-1 viral load from baseline to day 15 |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability |  | 72 weeks |