Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
- Registration Number
- NCT00967187
- Lead Sponsor
- Myrexis Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MPC-4326 200 mg BID X 14 Days bevirimat dimeglumine - MPC-4326 300 mg BID X 14 Days. bevirimat dimeglumine -
- Primary Outcome Measures
Name Time Method Change in HIV-1 viral load from baseline to day 15 15 days
- Secondary Outcome Measures
Name Time Method To evaluate safety and tolerability 72 weeks
Trial Locations
- Locations (4)
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