This session will demonstrate how USC Sumter's Anderson Library recently developed informa- tion literacy and research skills program uses information technology available through the li- brary introduce students, faculty and patrons to the methods and ethics of information research, with an emphasis on analyzing and defining information needs and resources by presenting it in multiple formats. During the Spring 2005 semester we used Camtasia™ to record both image and voice for in- structional use outside the classroom. Our goal was to reach every student member of our cam- pus and educate them on the offerings available in the library. Selected faculty received a CD tailored to their specific needs in the library. We used previous bibliographic instruction records to select the initial group of educators for the CD system. The library intends to provide this type of resource for any faculty member based on their feedback and their needs.
The safety, antiretroviral activity, and pharmacokinetic profile of nelfinavir, a potent and specific inhibitor of human immunodeficiency virus (HIV) protease, were assessed in a small open‐label phase I/II dose‐ranging study in protease inhibitor‐naive HIV‐positive men. A total of 22 patients with baseline plasma HIV RNA ≥ 20,000 copies/mL and CD4+ counts between 200 and 500 cells/mm3 were enrolled in the study. Of the 22 patients, 20 were evaluated for activity; 10 patients assigned to 771 mg/day base equivalent (300 mg three times daily) and 10 patients assigned to 1,026 mg/day base equivalent (600 mg twice daily) given monotherapy. A capsule formulation of nelfinavir was used. The initial study period was 28 days; patients showing a virologic response of 1 log10 reduction were eligible for enrollment in an extension phase and addition of nucleoside analogues. A maximally tolerated dose of nelfinavir was not established. A dose‐response relationship was observed for four (40%) patients in the 771‐mg group and six (60%) patients in the 1,026‐mg group experiencing a reduction from baseline in plasma HIV RNA of at least 1 log during the 28‐day study. Of these patients, five sustained the reduction in plasma HIV RNA beyond day 28 (2 patients receiving 771 mg/day and 3 patients receiving 1,026 mg/day). Median increases from baseline in CD4+ counts at day 28 were 216 cell/mm3 and 86 cell/mm3 in the 771‐mg and 1,026‐mg groups, respectively. After oral administration, median nelfinavir plasma concentrations on day 28 reached a maximum at 1 hour (2,966 ng/mL) in the 771‐mg group and at 3 hours (3,157 ng/mL) in the 1,026‐mg group. Data for 22 patients were included in the safety analysis; 12 patients (55%) reported at least one grade 2 or worse (moderate, severe, or very severe) adverse event. The most common grade 2 or worse adverse event was diarrhea, reported by two patients (20%) receiving 771 mg/day and seven patients (70%) receiving 1,026 mg/day; followed by nausea, flatulence, asthenia, and headache (each reported in 1 patient [10%] in the 771‐mg group) and dizziness (reported in 1 patient [10%] receiving 1,026 mg/day). In the small subgroup (n = 6) who continued taking nelfinavir for longer periods (between 8 and 15 months), virologic responses were sustained in the majority of patients with good tolerability. Nelfinavir is an active HIV‐protease inhibitor with favorable pharmacokinetics, good tolerability, and sustained antiviral effects. Results of this early phase I/II dose‐ranging study provided data for the safety and antiretroviral activity of nelfinavir and led to the selection of higher doses for phase II/III trials to further optimize virologic and immunologic responses.
A phase I/II dose-ranging open-label 28-day monotherapy study of the safety, pharmacokinetics, and antiviral activity of nelfinavir mesylate (Viracept), an inhibitor of human immunodeficiency virus (HIV)-1 protease, was done in 65 HIV-l-infected subjects, After 28 days, 54 responding subjects entered an open-label extension that allowed for the addition of nucleoside inhibitors of reverse transcriptase and dose escalation to maintain durability. The drug was well-tolerated and demonstrated robust antiviral activity, with demonstrable superiority of the 750 mg and 1000 mg three times daily regimens. Thirty subjects who continued to receive therapy at 12 months attained a persistent 1.6 log(10) reduction in HIV RNA, accompanied by a mean increase in CD4 cells of 180-200/mm(3). Studies of viral genotype and phenotype after virus rebound revealed that the initial active site mutation allowing for nelfinavir resistance is mediated by a unique amino acid substitution in the HIV-1 protease D30N, which does not confer in vitro phenotypic cross-resistance to the currently available protease inhibitors.
Nelfinavir mesylate (formerly AG1343) is a potent and selective inhibitor of human immunodeficiency virus (HIV) protease approved for the treatment of individuals infected with HIV. Nucleotide sequence analysis of protease genes from plasma HIV type 1 (HIV-1) RNA revealed a unique aspartic acid (D)-to-asparagine (N) substitution at residue 30 (D30N) in 25 of 55 patients treated with nelfinavir for a median of 13 weeks. Although the appearance of D30N was occasionally associated with concurrent or sequential emergence of other changes (e.g., at residues 35, 36, 46, 71, 77, and 88), genotypic changes associated with phenotypic resistance to other protease inhibitors were not observed (e.g., at residues 48, 50, 82, and 84) or were only rarely observed (e.g., at residue 90). In phenotypic assays, viral isolates with high-level resistance to nelfinavir remained susceptible to indinavir, saquinavir, ritonavir, and amprenavir (formerly VX-478/141W94). Similar results were observed in phenotypic assays utilizing HIV-1 NL4-3, which contained the D30N substitution alone or in combination with substitutions at other residues (e.g., residues 46, 71, and 88). These data indicate that the initial pathway of resistance to nelfinavir is unique and suggest that individuals failing short courses of nelfinavir-containing regimens may respond to regimens containing other protease inhibitors.
Based on favorable results from a phase I study of AG1343 using oral doses of 800 mg and 400 mg, a new study assessed a 300 mg dose regimen as the starting dose for a 1-month pilot phase II trial in HIV-positive patients with CD4 counts between 200 and 500. One patient was assessed who had been diagnosed in 1994 with HIV and had no prior HIV therapy or current medications. Results from HIV RNA titers, p24 antigen levels, and CD4 counts over a 9 to 14 day period showed increases in CD4 counts and decreases in viral load.
Eighteen children from3weeksto6.9yearsofage were given an oral acyclovir suspension forherpes simplex orvaricella-zoster virus infections. Thirteen patients whowere 6monthsto6.9yearsoldreceived 600mg/M2 perdose, andthree infants andtwochildren less than2yearsoldwere given 300mg/M2per dose. Thedrug was given fourtimes aday,except tooneinfant whowas treated withthree doses aday.Amongthe13children whoreceived the600-mg/M2 dose, themaximumconcentration inplasma(Cmax) was 0.99 0.38p,g/ml (mean + standard deviation), thetimetomaximumconcentration (Tmax) was 3.0 0.86h,theareaunderthecurve (AUC)was 5.56 2.17p,gh/ml, andtheelimination half-life (tl/2) was 2.59 0.78h.Thethree infants less than2monthsofagewhoreceived the300-mg/M2 dosehadaCmaxof1.88 ± 1.11,g/ml, a Tmaxof4.10 ± 0.48 h,an AUC of6.54 ± 4.32,uggh/ml, andatl/2 of3.26 ± 0.33h.Theacyclovir suspension was welltolerated byyoungchildren. Noadverse effects requiring discontinuation ofthedrugoccurred. Acyclovir (9-(2-hydroxyethoxymethyl)guanine)
This session will demonstrate how USC Sumter’s Anderson Library recently developed information literacy and research skills program uses information technology available through the library introduce students, faculty and patrons to the methods and ethics of information research, with an emphasis on analyzing and defining information needs and resources by presenting it in multiple formats. During the Spring 2005 semester we used Camtasia™ to record both image and voice for instructional use outside the classroom. Our goal was to reach every student member of our campus and educate them on the offerings available in the library. Selected faculty received a CD tailored to their specific needs in the library. We used previous bibliographic instruction records to select the initial group of educators for the CD system. The library intends to provide this type of resource for any faculty member based on their feedback and their needs.
Eighteen children from3weeksto6.9yearsofage were given an oral acyclovir suspension forherpes simplex orvaricella-zoster virus infections. Thirteen patients whowere 6monthsto6.9yearsoldreceived 600mg/M2 perdose, andthree infants andtwochildren less than2yearsoldwere given 300mg/M2per dose. Thedrug was given fourtimes aday,except tooneinfant whowas treated withthree doses aday.Amongthe13children whoreceived the600-mg/M2 dose, themaximumconcentration inplasma(Cmax) was 0.99 0.38p,g/ml (mean + standard deviation), thetimetomaximumconcentration (Tmax) was 3.0 0.86h,theareaunderthecurve (AUC)was 5.56 2.17p,gh/ml, andtheelimination half-life (tl/2) was 2.59 0.78h.Thethree infants less than2monthsofagewhoreceived the300-mg/M2 dosehadaCmaxof1.88 ± 1.11,g/ml, a Tmaxof4.10 ± 0.48 h,an AUC of6.54 ± 4.32,uggh/ml, andatl/2 of3.26 ± 0.33h.Theacyclovir suspension was welltolerated byyoungchildren. Noadverse effects requiring discontinuation ofthedrugoccurred. Acyclovir [9-(2-hydroxyethoxymethyl)guanine]