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

NCT00967187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-01-06

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • Myrexis Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Beelen, MD · Myrexis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967187 on ClinicalTrials.gov