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HIV InfectionsPhase 2NCT01026727

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 study testing MPC-4326 plus a 2-3 drug optimized background regimen (OBR) and 3-4 commercially available antiretroviral drugs in people with HIV Infections, run by Myrexis Inc. at 25 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
MPC-4326 plus a 2-3 drug optimized background regimen (OBR) and 3-4 commercially available antiretroviral drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
25 sitesin 2 countries
Study dates
Nov 2009to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Have a screening plasma HIV-1 RNA value ≥ 1,000 copies/mL
  • Be receiving an ARV regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to initial screening.
  • 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.
  • 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
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  • Must have wild type Gag at position 370 (i.e., no polymorphisms at 370)
  • 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.
  • 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.

Who cannot join

  • Be pregnant or breast feeding
  • Presence of any significant acute illness (as determined by the investigator) within 14 days of study entry.
  • 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).
  • A history of cerebrovascular accident or transient ischemic attacks.
  • Subjects with the following laboratory parameters within 14 days prior to first dose of study drug:
  • Hemoglobin < 10 g/dL for men and < 9 g/dL for women
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  • Absolute neutrophil count < 1000/mm3
  • Platelet count < 50,000/mm3
  • 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
  • Calculated creatinine clearance (ClCr) <40 mL/min as determined by the Cockcroft-Gault equation
  • Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
  • 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.
  • Subjects who use or require a prohibited therapy within 30 days prior to or while participating in this study.
  • 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.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States21 sites

  • CARE-ID

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • AIDS Healthcare Foundation Research Center

    Beverly Hills, California, 90211

  • Community Research Initiative of New England

    Boston, Massachusetts, 2215

  • Southwest Infectious Disease

    Dallas, Texas, 75204

  • North Texas Infectious Disease Consultants, PA

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary J. Richmond, MD, PA

    Fort Lauderdale, Florida, 33316

  • Therapeutic Concepts, P.A

    Houston, Texas, 77004

  • DCOL Center

    Longview, Texas, 75605

  • Peter Wolfe, MD, PC

    Los Angeles, California, 90036

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Orlando Immunology Center

    Orlando, Florida, 32803-1851

  • Kaiser Permanente Immune Deficiency Clinic

    Portland, Oregon, 97227

  • University of Rochester , Strong Memorial Hospital

    Rochester, New York, 14642

  • Quest Clinical Research

    San Francisco, California, 94115

  • EHS Pulmonary & Critical Care

    Spokane, Washington, 99204

  • North Bronx Health Care Network

    The Bronx, New York, 10461

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20009

Other trials in United States

Canada4 sites

  • Clinique médicale l'Actuel,

    Montreal, Quebec, H2L 4P9

  • Clinique Médicale Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University of British Columbia,Downtown Infectuous Diseases Clinic

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

About this study

Official title: A Phase 2b Multicenter, Randomized, Open Label, Comparative Trial of MPC-4326 in Combination With a Two to Three Drug Optimized Background Regimen Versus an Optimized, Three to Four Drug Antiretroviral Regimen for the Treatment of Triple Class Antiretroviral Experienced, HIV-1 Infected Subjects Failing Current Therapy

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.

Conditions
HIV Infections
Being tested
MPC-4326 plus a 2-3 drug optimized background regimen (OBR), 3-4 commercially available antiretroviral drugs
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
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, Virus Diseases, Sexually Transmitted Diseases, Viral, RNA Virus Infections, Slow Virus Diseases, Immune System Diseases, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 3-4 commercially available antiretroviral drugsDrug

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

Study groups in NCT01026727
Study groupRoleWhat they receive
MPC-4326 plus a 2-3 drug optimized background regimen (OBR)ExperimentalMPC-4326 300 mg or 400mg BID plus a 2-3 drug optimized background regimen (OBR)for 24 weeks.
Receives: Drug: MPC-4326 plus a 2-3 drug optimized background regimen (OBR)
3-4 drug antiretroviral drugsActive comparator3-4 commercially available antiretroviral (ARV)drugs for 24 weeks.
Receives: Drug: 3-4 commercially available antiretroviral drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24-weeks

Secondary outcomes (1)

  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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJun 2010
  4. Study completionJun 2010

Why it stopped: For strategic buisness reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026727
Sponsor's protocol ID
MPC-4326-003.01
Status last verified
Jun 2010
First submitted
2 Dec 2009
Last updated
14 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPC-4326 plus a 2-3 drug optimized background regimen (OBR) and 3-4 commercially available antiretroviral drugs in people with HIV Infections, run by Myrexis Inc. at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: For strategic buisness reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a viral load <50 copies/mL at 24 weeks in each treatment group (time frame: 24-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.

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Clinical Trial NCT01026727 | AzTrials