CClinicalTrials.gg
TerminatedNCT01026727Updated Jun 14, 2010

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

A Phase 2 interventional study of MPC-4326 plus a 2-3 drug optimized background regimen (OBR) and 3-4 commercially available antiretroviral drugs in HIV Infections, sponsored by Myrexis Inc.. Terminated at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-14.

Sponsored by Myrexis Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
For strategic buisness reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a 3-4 antiretroviral (ARV) regimen in treatment experienced, HIV-1 infected subjects.

Read the detailed description

Standard antiretroviral therapies for the treatment of HIV/AIDS, while effective for varying lengths of time, can be rendered inadequate for viral suppression by the emergence of drug resistant virus, which can include resistance to entire mechanistic classes of drugs. Thus, there exists a significant unmet medical need for new highly potent antiretroviral agents with novel mechanisms of action. The novel mechanism of action of MPC-4326 suggests that MPC-4326 may have utility for the treatment of HIV-1 infected patients failing current regimens due to the development of drug resistance.

02

Conditions studied

  • HIV Infections

Keywords

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Virus Diseases
  • Sexually Transmitted Diseases, Viral
  • RNA Virus Infections
  • Slow Virus Diseases
  • Immune System Diseases
  • Sexually Transmitted Diseases
  • Lentivirus Infections
  • Infection
  • Retroviridae Infections
  • Immunologic Deficiency Syndromes
  • HIV
  • treatment experienced
  • bevirimat
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 2 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Myrexis Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily consent to participate in the study (sign Informed Consent Form), and able to understand study procedures and complete the study.
  2. Be at least 18 years of age at the time of screening.
  3. Have a screening plasma HIV-1 RNA value ≥ 1,000 copies/mL
  4. Be receiving an ARV regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to initial screening.
  5. Have at least two fully active ARVs (exclusive of MPC-4326) as determined by a 'maximal response' on the vircoTYPE assay; R5 tropism testing (if applicable); and treatment history (e.g., naïve to enfuvirtide or integrase inhibitors) that can be combined in a regimen containing a maximum of four ARVs for the 3-4d ARV regimen or three ARVs for the 2-3-drug OBR to be combined with MPC-4326.
  6. Two NRTIs are not allowed as the only fully-active antiretroviral agents in the 3-4-drug ARV regimen or in the 2-3-drug OBR
  7. Must have wild type Gag at position 370 (i.e., no polymorphisms at 370)
  8. Have resistance to at least one agent in each of the three 'classic' ARV drug classes (NRTI, NNRTI, PI) to include documented evidence of resistance on prior resistance tests.
  9. Females of childbearing potential must agree to the use two forms of contraception from the time of screening until 90 days after completion of dosing.Surfactant-type spermicide gels and contraceptive foam are not recommended, as they increase the rate of HIV transmission.

Exclusion criteria

Exclusion Criteria:

  1. Be pregnant or breast feeding
  2. Presence of any significant acute illness (as determined by the investigator) within 14 days of study entry.
  3. Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry (i.e., Run in Period Day 1).
  4. A history of cerebrovascular accident or transient ischemic attacks.
  5. Subjects with the following laboratory parameters within 14 days prior to first dose of study drug:

    1. Hemoglobin \< 10 g/dL for men and \< 9 g/dL for women
    2. Absolute neutrophil count \< 1000/mm3
    3. Platelet count \< 50,000/mm3
    4. AST or ALT > 5 times the upper limit of normal inclusive of subjects with a positive HBV surface antigen or HCV antibody test at screening
    5. Calculated creatinine clearance (ClCr) \<40 mL/min as determined by the Cockcroft-Gault equation
  6. Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
  7. Subjects who have received treatment with immunomodulating agents such as IL-2, α IFN, β IFN or γ IFN within 4 weeks prior to the first dose of study drug.
  8. Subjects who use or require a prohibited therapy within 30 days prior to or while participating in this study.
  9. Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication. For investigational drugs with an elimination half life greater than 10 days, this period will be extended to 60 days and for antibody-based products (i.e., CD4 antibody products, etc.) this period will be extended to 3 months.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

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

    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)

  • Active comparator
    3-4 drug antiretroviral drugs

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

    Drug: 3-4 commercially available antiretroviral drugs

Interventions

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

    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

  • Drug3-4 commercially available antiretroviral drugs

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

06

What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: 24 weeks

07

Study locations

25 sites
  • 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, 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
    Miami Beach, Florida 33139, United States
  • Orlando Immunology Center
    Orlando, Florida 32803-1851, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • Community Research Initiative of New England
    Boston, Massachusetts 2215, United States
  • North Bronx Health Care Network
    Bronx, New York 10461, United States
  • University of Rochester , Strong Memorial Hospital
    Rochester, New York 14642, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Kaiser Permanente Immune Deficiency Clinic
    Portland, Oregon 97227, United States
  • Central Texas Clinical Research
    Austin, Texas 78705, United States
  • Southwest Infectious Disease
    Dallas, Texas 75204, United States
  • North Texas Infectious Disease Consultants, PA
    Dallas, Texas 75246, United States
  • Therapeutic Concepts, P.A
    Houston, Texas 77004, United States
  • DCOL Center
    Longview, Texas 75605, United States
  • CARE-ID
    Annandale, Virginia 22003, United States
  • EHS Pulmonary & Critical Care
    Spokane, Washington 99204, United States
  • University of British Columbia,Downtown Infectuous Diseases Clinic
    Vancouver, British Columbia V6Z 2C7, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
  • Clinique médicale l'Actuel,
    Montreal, Quebec H2L 4P9, Canada
  • Clinique Médicale Quartier Latin
    Montreal, Quebec H2L 5B1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01026727
Lead sponsor
Myrexis Inc.
First posted
Dec 4, 2009
Start date
Nov 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jun 14, 2010

Study contacts

Andrew Beelen, MD
study director · Myrexis Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion