Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

HIV InfectionsAcquired Immunodeficiency SyndromeVirus DiseasesSexually Transmitted Diseases, ViralRNA Virus InfectionsSlow Virus DiseasesImmune System DiseasesSexually Transmitted DiseasesLentivirus InfectionsInfectionRetroviridae InfectionsImmunologic Deficiency SyndromesHIVtreatment experiencedbevirimat

Outcome Measures

Primary Outcomes (1)

Proportion of subjects with a viral load <50 copies/mL at 24 weeks in each treatment group
24-weeks

Secondary Outcomes (1)

The key secondary endpoint is to compare the Viral Load Decrease at 24 weeks in the two treatment arms. VLD is defined as the change from baseline log10 viral load.
24 weeks

Study Arms (2)

MPC-4326 plus a 2-3 drug optimized background regimen (OBR)

EXPERIMENTAL

MPC-4326 300 mg or 400mg BID plus a 2-3 drug optimized background regimen (OBR)for 24 weeks.

Drug: MPC-4326 plus a 2-3 drug optimized background regimen (OBR)

3-4 drug antiretroviral drugs

ACTIVE COMPARATOR

3-4 commercially available antiretroviral (ARV)drugs for 24 weeks.

Drug: 3-4 commercially available antiretroviral drugs

Interventions

MPC-4326 plus a 2-3 drug optimized background regimen (OBR)Drug

For treatment arm #1: the MPC-4326 dose will be selected based on the inclusion of raltegravir (i.e., will be limited to 300 mg BID) or inclusion of darunavir (i.e., will be assigned 400 mg BID) in the OBR. If both raltegravir and darunavir are included in the OBR for a subject, the subject will be limited to 300 mg BID

MPC-4326 plus a 2-3 drug optimized background regimen (OBR)

3-4 commercially available antiretroviral drugsDrug

For treatment arm #2: the antiretroviral regimen, dosage and frequency will be selected by the investigator.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily consent to participate in the study (sign Informed Consent Form), and able to understand study procedures and complete the study.
Be at least 18 years of age at the time of screening.

Sponsors & Collaborators

Myrexis Inc.
Industrylead

Study Sites (25)

AIDS Healthcare Foundation Research Center

Beverly Hills, California, 90211, United States

Peter Wolfe, MD, PC

Los Angeles, California, 90036, United States

Quest Clinical Research

San Francisco, California, 94115, United States

Whitman Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Gary J. Richmond, MD, PA

Fort Lauderdale, Florida, 33316, United States

Wohlfeiler, Piperato and Associates, LLC

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeVirus DiseasesSexually Transmitted Diseases, ViralRNA Virus InfectionsSlow Virus DiseasesImmune System DiseasesSexually Transmitted DiseasesLentivirus InfectionsInfectionsRetroviridae InfectionsImmunologic Deficiency Syndromes

Interventions

bevirimat

Condition Hierarchy (Ancestors)

Blood-Borne Infections

Study Officials

Andrew Beelen, MD
Myrexis Inc.
STUDY DIRECTOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 4, 2009

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

A Study to Assess the Long-term Efficacy (24 Weeks) of MPC-4326 in Combination With a 2-3 Drug OBR Relative to the Efficacy of a 3-4 Drug ARV Regimen in Treatment Experienced HIV-1 Infected Subjects Who Are Failing Current Antiretroviral Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

MPC-4326 plus a 2-3 drug optimized background regimen (OBR)

3-4 drug antiretroviral drugs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

MPC-4326 plus a 2-3 drug optimized background regimen (OBR)

3-4 drug antiretroviral drugs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations