A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days
- Registration Number
- NCT01097070
- Lead Sponsor
- Myrexis Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bevirimat 400 mg once daily, 15 days Bevirimat - Bevirimat 300 mg once daily, 15 days Bevirimat - Bevirimat 200 mg twice daily, 15 days Bevirimat -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (4)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Gary J. Richmond, MD, PA
🇺🇸Ft. Lauderdale, Florida, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States