Clinical trial NCT01097070: A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infection
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 16 days
Secondary outcomes:
measure: 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.
timeFrame: Day 15
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Ft. Lauderdale
country: United States
facility: Gary J. Richmond, MD, PA
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
Study officials:
affiliation: Myrexis Inc.
name: Andrew Beelen, MD
role: STUDY_DIRECTOR
affiliation: Quest Clinical Research
name: Jacob P Lalezari, MD
role: PRINCIPAL_INVESTIGATOR
name: Gary J Richmond, MD, PA
role: PRINCIPAL_INVESTIGATOR
affiliation: AIDS Research Consortium of Atlanta
name: Melanie A Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research Initiative of New England
name: Calvin J Cohen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: