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

NCT01097070 | Completed Phase 2

• 1 other identifier: Bevirimat Study 206
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Bevirimat 200 mg twice daily, 15 days

EXPERIMENTAL

Drug: Bevirimat

Bevirimat 300 mg once daily, 15 days

EXPERIMENTAL

Drug: Bevirimat

Bevirimat 400 mg once daily, 15 days

EXPERIMENTAL

Drug: Bevirimat

Interventions

Bevirimat DRUG

Also known as: MPC-4326

Bevirimat 200 mg twice daily, 15 days; Bevirimat 300 mg once daily, 15 days; Bevirimat 400 mg once daily, 15 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (4)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Gary J. Richmond, MD, PA

Fort Lauderdale, Florida, 33316, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

bevirimat

Study Officials

• Andrew Beelen, MD

  Myrexis Inc.

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: April 1, 2010
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 1, 2010

Record last verified: 2010-03

Locations

US (4)