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

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 Optimised Backround Regimen for a maximum of 72 weeks.

Official Title

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.

Conditions

• HIV infections

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

• Change in HIV-1 viral load from baseline to day 15
  [ Time Frame: 15 days ]
  [ Designated as safety issue: No ]

Secondary outcome measures

• To evaluate safety and tolerability
  [ Time Frame: 72 weeks ]
  [ Designated as safety issue: Yes ]

Study arms and assigned interventions

1. MPC-4326 200 mg BID X 14 Days:
   • Experimental 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 optimised background regimen (OBR) through Week 72.
2. MPC-4326 300 mg BID X 14 Days:
   • Experimental 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 optimised background regimen (OBR) through Week 72.

Study Start

May 2008 – March 2010

Eligibility & Criteria

• Ages eligible for study: 18 years and older
• Genders eligible for study: Both
• Accepts 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 paediatric febrile seizures) or current administration of prophylactic anti-seizure medications; 
• A history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA);
• Patients with the following laboratory parameters within 30 days prior to first dose of study drug:
  • Haemoglobin < 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).

Total Enrolment

32

Contact Details