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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: bevirimat dimeglumine; Drug: bevirimat dimeglumine

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Darlinghurst, New South Wales, Australia, 2010
      • Taylor Square Private Clinic
    • Darlinghurst, New South Wales, Australia, 2010
      • AIDS Research Initiative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MPC-4326 200 mg BID X 14 Days	Drug: bevirimat dimeglumine; 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.; Drug: bevirimat dimeglumine; 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.
Experimental: MPC-4326 300 mg BID X 14 Days.	Drug: bevirimat dimeglumine; 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.; Drug: bevirimat dimeglumine; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate safety and tolerability	72 weeks

Collaborators and Investigators

• Sponsor: Myrexis Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): January 6, 2010
• Last Update Submitted That Met QC Criteria: January 4, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: MPC-4326-204; BVM Study 204