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

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097070
• Other study ID #: Bevirimat Study 206
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2010
• Last updated: March 30, 2010
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2010
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• Bevirimat

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Community Research Initiative of New England	Boston	Massachusetts
United States	Gary J. Richmond, MD, PA	Ft. Lauderdale	Florida
United States	Quest Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No