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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967187
• Other study ID #: MPC-4326-204
• Secondary ID: BVM Study 204
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2009
• Last updated: January 4, 2010
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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 optimized background regimen (OBR) through Week 72.
• 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 optimized background regimen (OBR) through Week 72.

Locations

Country	Name	City	State
Australia	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

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HIV-1 viral load from baseline to day 15		15 days	No
Secondary	To evaluate safety and tolerability		72 weeks	Yes