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

This study has been completed.
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00967187
First received: August 25, 2009
Last updated: January 4, 2010
Last verified: January 2010

August 25, 2009
January 4, 2010
May 2008
November 2009   (final data collection date for primary outcome measure)
Change in HIV-1 viral load from baseline to day 15 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967187 on ClinicalTrials.gov Archive Site
To evaluate safety and tolerability [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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.
  • 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 optimized background regimen (OBR) through Week 72.
  • Experimental: MPC-4326 200 mg BID X 14 Days
    Intervention: Drug: bevirimat dimeglumine
  • Experimental: MPC-4326 300 mg BID X 14 Days.
    Intervention: Drug: bevirimat dimeglumine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2009
November 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00967187
MPC-4326-204, BVM Study 204
Yes
Andrew Beelen, M.D., Study Director, Myriad Pharmaceuticals
Myrexis Inc.
Not Provided
Study Director: Andrew Beelen, MD Myrexis Inc.
Myrexis Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP