Back to resultsSafety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
bevirimat dimeglumine
bevirimat dimeglumine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
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)
Sites / Locations
- AIDS Research Initiative
- Holdsworth House Medical Practice
- St Vincent's Hospital
- Taylor Square Private Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MPC-4326 200 mg BID X 14 Days
MPC-4326 300 mg BID X 14 Days.
Arm Description
Outcomes
Primary Outcome Measures
Change in HIV-1 viral load from baseline to day 15
Secondary Outcome Measures
To evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967187
Brief Title
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Myrexis Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MPC-4326 200 mg BID X 14 Days
Arm Type
Experimental
Arm Title
MPC-4326 300 mg BID X 14 Days.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevirimat dimeglumine
Intervention Description
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
Intervention Name(s)
bevirimat dimeglumine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HIV-1 viral load from baseline to day 15
Time Frame
15 days
Secondary Outcome Measure Information:
Title
To evaluate safety and tolerability
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Beelen, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AIDS Research Initiative
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
12. IPD Sharing Statement
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Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
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