Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*
NCT ID: NCT00511368
Last Updated: 2010-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2006-04-30
2008-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days
NCT01097070
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
NCT00967187
Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
NCT06544733
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
NCT00053638
An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
NCT00000747
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
placebo
matching placebo
2
Bevirimat
matching placebo
Bevirimat
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
matching placebo
Bevirimat
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Myrexis Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Myriad Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Beelen, M.D.
Role: STUDY_DIRECTOR
Myrexis Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Medical Center
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Colorado Health Science Center
Denver, Colorado, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
Gary Richmond
Fort Lauderdale, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
The Research Insitute
Boston, Massachusetts, United States
UNC at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Miriam Hospital/Brown University
Providence, Rhode Island, United States
Central Texas Clinical Research
Austin, Texas, United States
Southwest Infectious Diseases
Dallas, Texas, United States
University of Texas Medical Branch Internal Medicine
Galveston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Related Info
Related Info
Related Info
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PA103001-04 Study 203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.