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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: bevirimat dimeglumine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

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 ]

Estimated Enrollment: 32
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MPC-4326 200 mg BID X 14 Days 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.
Experimental: MPC-4326 300 mg BID X 14 Days. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967187

Locations
Australia, New South Wales
AIDS Research Initiative
Darlinghurst, New South Wales, Australia, 2010
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Andrew Beelen, MD Myrexis Inc.
  More Information

No publications provided

Responsible Party: Andrew Beelen, M.D., Study Director, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00967187     History of Changes
Other Study ID Numbers: MPC-4326-204, BVM Study 204
Study First Received: August 25, 2009
Last Updated: January 4, 2010
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014