Status:
COMPLETED
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
Lead Sponsor:
Myrexis Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00967187
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 6 2010
Active Locations (4)
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1
AIDS Research Initiative
Darlinghurst, New South Wales, Australia, 2010
2
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
3
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
4
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia, 2010