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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
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.
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
Change in HIV-1 viral load from baseline to day 15
Time frame: 15 days
To evaluate safety and tolerability
Time frame: 72 weeks
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