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

NCT ID: NCT00967187

Last Updated: 2010-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MPC-4326 200 mg BID X 14 Days

Group Type: EXPERIMENTAL

bevirimat dimeglumine

Intervention Type: 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.

MPC-4326 300 mg BID X 14 Days.

Group Type: EXPERIMENTAL

bevirimat dimeglumine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Myrexis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Myriad Pharmaceuticals

Principal Investigators

Andrew Beelen, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

AIDS Research Initiative

Darlinghurst, New South Wales, Australia

Holdsworth House Medical Practice

Darlinghurst, New South Wales, Australia

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia

Countries

Australia

Other Identifiers

BVM Study 204

Identifier Type: -

Identifier Source: secondary_id

MPC-4326-204

Identifier Type: -

Identifier Source: org_study_id