HIV-1 Infection
Conditions
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.
Interventions
DRUGBevirimat
Sponsors
Myrexis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed