- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511368
Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*
January 15, 2010 updated by: Myrexis Inc.
Phase 2 Dose-escalating, P-C, D-B, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days *(PART B)
The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs.
Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bevirimat (PA103001-04) represents a new class of antivirals that blocks HIV replication by disrupting virus maturation; specifically, by inhibiting a late step in the Gag processing cascade.
Short term (7-10 days) functional monotherapy studies (conducted in patients with detectable viral loads on a failing regimen)help in determining the potency of the drug, and enable dose finding.
This is a two part (A and B)randomized, placebo-controlled, double-blind, multiple-dose, dose-escalation study in HIV treatment-experienced patients on a failing regimen (harboring resistance mutations to at least one member of the NRTI, NNRTI or PI classes.
The antiretroviral activity, safety, and pharmacokinetics of up to 5 different dose levels of bevirimat will be compared to placebo when added to a failing approved antiretroviral regimen.
The study is conducted in two parts: A and B. In Part A following 14 days of daily dosing patients commenced a new optimized ART regimen in addition to their randomized treatment.
In Part Part B dosing with the randomized treatment ends after the initial 14 days of daily dosing.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90035
- UCLA Medical Center
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San Francisco, California, United States, 94115
- Quest Clinical Research
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-
Colorado
-
Denver, Colorado, United States, 80262
- University of Colorado Health Science Center
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-
District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Medical Center
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Washington, District of Columbia, United States, 20037
- Whitman-Walker Clinic
-
-
Florida
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Fort Lauderdale, Florida, United States, 33316
- Gary Richmond
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Orlando, Florida, United States, 32803
- Orlando Immunology Center
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-
Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta, Inc.
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-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02215
- The Research Insitute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC at Chapel Hill
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-
Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel University College of Medicine
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hospital/Brown University
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Texas
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Austin, Texas, United States, 78705
- Central Texas Clinical Research
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Dallas, Texas, United States, 75204
- Southwest Infectious Diseases
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Galveston, Texas, United States, 77210-4786
- University of Texas Medical Branch Internal Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female. Females of child-bearing potential, must have a documented negative pregnancy test and be willing to utilize double-barrier contraception through-out the study period.
- Have HIV-1-infection.
- Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of 2,000 - 250,000 copies/ml (inclusive).
- Have documented evidence of genotypic resistance in their medical records (at screening) or have resistance at screening by genotype to any major mutation from the IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R, D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H, G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V, I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M
- Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens containing ritonavir must not exceed a total daily dose of 400 mg) which has been unchanged for at least 8 weeks prior to initial screening.
- Be able to receive an optimized background regimen.
- Be free from any acute infection or serious medical illness within 14 days prior to study entry.
- Be informed of the nature of the study and provide written informed consent.
- Be willing to comply with the meal requirements described in the protocol.
Exclusion Criteria:
- Current opportunistic infection characteristic of AIDS
- Patients unable or unwilling to comply with the dosing schedule and protocol evaluations.
- Patients with malabsorption syndromes affecting drug absorption.
- Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood pressure < 60 mmHg or > 90 mmHg measured in a semi-recumbent position after at least 10 minutes of rest at the screening or qualification visit.
- A history of seizures (excluding pediatric febrile seizures), migraines, cluster and/or chronic headaches, cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
- Patients with abnormal Hemoglobin (< 10.0 g/dL for men and < 9.0 g/dL for women), Neutrophil count (< 1000/mm3), Platelet count (< 100,000/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)
- Patients who have received radiation therapy or cytotoxic chemotherapeutic agents, immunomodulating agents, HIV immunotherapeutic vaccine, an investigational drug or product, or participation in a drug study within 4 weeks prior to the first dose of study drug.
- A history of alcoholism or drug addiction within the past 1 year (unless enrolled in a treatment program and approved by the sponsor). Recent use of any recreational drugs (except marijuana).
- A history of difficulty donating blood or inadequate venous access.
- The donation of blood or plasma within 30 days prior to receiving study medication.
Note: patients with a CD4 count <100 cells/mm3 will be considered for enrollment following discussion and agreement between the Investigator and the Sponsor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
placebo
|
Other Names:
|
Experimental: 2
Bevirimat
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV-1 RNA change from baseline over the first 14 days of study
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety and tolerability; pharmacokinetics
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Andrew Beelen, M.D., Myrexis Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
August 1, 2007
First Submitted That Met QC Criteria
August 2, 2007
First Posted (Estimate)
August 3, 2007
Study Record Updates
Last Update Posted (Estimate)
January 20, 2010
Last Update Submitted That Met QC Criteria
January 15, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA103001-04 Study 203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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