NCT00967187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

August 25, 2009

Last Update Submit

January 4, 2010

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Change in HIV-1 viral load from baseline to day 15

    15 days

Secondary Outcomes (1)

  • To evaluate safety and tolerability

    72 weeks

Study Arms (2)

MPC-4326 200 mg BID X 14 Days

EXPERIMENTAL
Drug: bevirimat dimeglumine

MPC-4326 300 mg BID X 14 Days.

EXPERIMENTAL
Drug: bevirimat dimeglumine

Interventions

bevirimat dimeglumineDRUG

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.

MPC-4326 200 mg BID X 14 Days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AIDS Research Initiative

Darlinghurst, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

bevirimat

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Andrew Beelen, MD

    Myrexis Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

May 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

AU(4)