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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: Bevirimat

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Quest Clinical Research
  • Florida
    • Ft. Lauderdale, Florida, United States, 33316
      • Gary J. Richmond, MD, PA
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Community Research Initiative of New England

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bevirimat 200 mg twice daily, 15 days	Drug: Bevirimat; Other Names: MPC-4326
EXPERIMENTAL: Bevirimat 300 mg once daily, 15 days	Drug: Bevirimat; Other Names: MPC-4326
EXPERIMENTAL: Bevirimat 400 mg once daily, 15 days	Drug: Bevirimat; Other Names: MPC-4326

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	16 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Day 15

Collaborators and Investigators

• Sponsor: Myrexis Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (ESTIMATE): April 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 30, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: Bevirimat Study 206