HIV Infections
Conditions
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.
Interventions
DRUGbevirimat 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.
Sponsors
Myrexis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HIV-1 viral load from baseline to day 15 | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety and tolerability | 72 weeks |
Countries
Australia
Outcome results
None listed