A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days

This study has been completed.
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT01097070
First received: March 23, 2010
Last updated: March 30, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.


Condition Intervention Phase
HIV-1 Infection
Drug: Bevirimat
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter, Open-label, Randomized, Parrallel Group Study to Assess the Pharmacokinetics of Bevirimat (BVM) 100 mg Tablets Administered to HIV-1 Positive Patients for 15 Days

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevirimat 200 mg twice daily, 15 days Drug: Bevirimat
Other Name: MPC-4326
Experimental: Bevirimat 300 mg once daily, 15 days Drug: Bevirimat
Other Name: MPC-4326
Experimental: Bevirimat 400 mg once daily, 15 days Drug: Bevirimat
Other Name: MPC-4326

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable).
  • Have a CD4+ lymphocyte count >/= 100 cells/mm3.
  • Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of <400 copies/mL.
  • Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study.
  • Be informed of the nature of the study and provide written informed consent.
  • Be legally competent and able to communicate effectively with study personnel.
  • Be able and willing to comply with outpatient visits.

Exclusion Criteria:

  • Presence of any acute illness within 14 days prior to 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.
  • Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
  • Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis).
  • Patients with systolic blood pressure < 90 mmHg or > 160 mmHg or diastolic blood pressure < 50 mmHg or > 110 mmHg.
  • A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medication for the indication of seizures or seizure-related conditions.
  • A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
  • Patients who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to first dose of study drug.
  • Patients who have received treatment with immunomodulating agents such as IL-2, alpha-interferon, beta-interferon, or gamma-interferon within 4 weeks prior to first dose of study drug.
  • Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication.
  • Bupropion-containing products require at least a 14-day washout period and will not be approved for co-administration.
  • Rifampin or other rifamycin products require at least a 28-day washout period and will not be approved for coadministration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097070

Locations
United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
Gary J. Richmond, MD, PA
Ft. Lauderdale, Florida, United States, 33316
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Andrew Beelen, MD Myrexis Inc.
Principal Investigator: Jacob P Lalezari, MD Quest Clinical Research
Principal Investigator: Gary J Richmond, MD, PA
Principal Investigator: Melanie A Thompson, MD AIDS Research Consortium of Atlanta
Principal Investigator: Calvin J Cohen, MD, MSc Community Research Initiative of New England
  More Information

No publications provided

Responsible Party: Andrew Beelen, MD., Study Director, Myriad Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01097070     History of Changes
Other Study ID Numbers: Bevirimat Study 206
Study First Received: March 23, 2010
Last Updated: March 30, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 22, 2014