76 research outputs found
<b>Supplemental Material - EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B</b>
No full textSupplementary Material for EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B by Jordan J Feld, Eric Lawitz, Tuan Nguyen, Jacob Lalezari, Tarek Hassanein, Paul Martin, Steven-Huy Han, Douglas Dieterich, Jeanne-Marie Giard, Guy De La Rosa, Alaa Ahmad, Ed Luo, Annie L Conery, and Nathalie Adda in Antiviral Therapy.</p
Quantification of zidovudine and individual zidovudine phosphates in peripheral blood mononuclear cells by a combined isocratic high performance liquid chromatography radioimmunoassay method
No full textAn Open-Label Safety Study of Enfuvirtide Injection with a Needle-Free Injection Device or Needle/Syringe: The Biojector 2000 Open-Label Safety Study (BOSS)
No full textRestoration of blood total glutathione status and lymphocyte function following α-lipoic acid supplementation in patients with HIV infection
No full textObjectives: To determine whether supplementation with α-lipoic acid (ALA), a glutathione-replenishing disulfide, modulates whole blood total glutathione (GSH+GSSG) levels and improves lymphocyte function in human immunodeficiency virus (HIV)-infected subjects with history of unresponsiveness to highly active antiretroviral treatment (HAART). Design and setting: Randomized, double-blinded, placebo-controlled trial conducted at two study sites: an eye clinic at a county hospital in San Jose and a research clinic in San Francisco, California. Subjects: A total of 33 HIV-infected men and women with viral load \u3e 10,000 copies/cm3, despite HAART, aged 4447 years, approximately 36% nonwhite, were enrolled. Intervention: Patients were randomly assigned to receive either ALA (300 mg three times a day) or matching placebo for 6 months. Main outcome measures: The change over 6 months in blood total glutathione status, lymphocyte proliferation response to T-cell mitogens, CD4 cell count, and viral load in patients receiving ALA compared to placebo. Results: The mean blood total glutathione level in ALA-supplemented subjects was significantly elevated after 6 months (1.34 ± 0.79 vs. 0.81 ± 0.18 mmol/L) compared to insignificant change (0.76 ± 0.34 vs. 0.76 ± 0.22 mmol/L) in the placebo group (ALA vs. placebo: p = 0.04). The lymphocyte proliferation response was significantly enhanced or stabilized after 6 months of ALA supplementation compared to progressive decline in the placebo group (ALA vs. placebo: p \u3c 0.001 with phytohemagglutinin; p = 0.02 with anti-CD3 monoclonal antibody). A positive correlation was seen between blood total glutathione level and lymphocyte response to anti-CD3 stimulation (R 2 = 0.889). There was no significant change in either HIV RNA level or CD4 count over 6 months in the ALA-supplemented compared to the control group. Conclusion: Supplementation with α-lipoic acid may positively impact patients with HIV and acquired immune deficiency syndrome by restoring blood total glutathione level and improving functional reactivity of lymphocytes to T-cell mitogens. © 2008 Mary Ann Liebert, Inc
A Preclinical and Clinical Overview of the Nucleotide-Based Antiviral Agent Cidofovir (HPMPC)
No full textPharmacokinetics of once-daily Etravirine without and with Once-daily Darunavir/ritonavir in Antiretroviral-Naive HIV type-1-Infected Adults
No full textBackground A pharmacokinetic trial was conducted to evaluate the potential for once-daily etravirine in anti-retroviral regimens without and with darunavir/ritonavir. Methods During this multicentre, open-label, Phase IIa trial, treatment-naive patients aged ≥18 years with HIV type-1 (HIV-1) received etravirine 400 mg once daily with tenofovir disoproxil fumarate/emtricitabine 300/200 mg once daily from days 1–14; on days 15–28, darunavir/ritonavir 800/100 mg once daily was added. On day 29, etravirine was discontinued and patients continued with the other medications to day 42. Serial blood sampling for etravirine pharmacokinetics was performed over 24 h on day 14 and 28; patients fasted for ≥10 h prior to these visits. Results Of 23 enrolled patients (male 87%, Caucasian 39%), pharmacokinetic profiles for etravirine were available for 21 and 20 patients on day 14 and 28, respectively. The plasma concentration–time profile and pharmacokinetics for etravirine were unchanged with or without darunavir/ritonavir. The mean maximum plasma concentration (Cmax) was reached 4 h after administration and was 790 and 801 ng/ml on day 14 and 28, respectively; mean area under the plasma concentration–time curve (AUC) from before administration to 24 h after administration was 10,410 ng•h/ml on day 14 and 10,720 ng•h/ml on day 28. In a post-hoc analysis, etravirine Cmax was higher, minimum plasma concentration was lower and AUC was similar when compared with etravirine 200 mg twice daily. Conclusions Addition of darunavir/ritonavir to etravirine, all dosed once daily, did not have a clinically significant effect on the pharmacokinetics of etravirine. Findings support further investigation of etravirine 400 mg once daily in HIV-1-infected patients. (Trial registration number NCT00534352.) </jats:sec
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Loss of Cytomegalovirus-Specific CD4+ T Cell Responses in Human Immunodeficiency Virus Type 1-Infected Patients with High CD4+ T Cell Counts and Recurrent Retinitis
No full textClinical histories are reported for 2 patients treated with highly active antiretroviral therapy (HAART) who experienced multiple relapses of cytomegalovirus (CMV) retinitis, despite suppression of human immunodeficiency virus type 1 (HIV-1) viremia and improvement in CD4+ T cell counts (to >400 cells/μL). CMV-specific CD4+ T cell immune reconstitution was measured directly, using cytokine flow cytometry, which revealed persistent deficits in CMV-specific CD4+ T cell responses in both patients. CMV-specific T cells constituted 0.14% and 0.05% of the total CD4+ T cell count in these patients, which is significantly lower than the percentages for 34 control subjects (0.6%-46%; CD4+ T cell count range, 7-1039 cells/μL; P=.019). Deficits in pathogen-specific immune responses may persist in some individuals, despite suppression of HIV-1 replication and substantial increases in circulating CD4+ T cells after HAART, and such deficits may be associated with significant morbidity from opportunistic infection
Individual P-values for longitudinal panels in macaques.
No full textTable shows the weekly P-values for longitudinal panels in plasma viral load (Fig 3D), CCR5+ CD4+ T-cells (Fig 3E), CCR5+ CD8+ T-cells (S7H Fig), lymphocyte (S5B Fig), CD4+ T-cell (S5C Fig), and CD8+ T-cell (S5D Fig). P-values were calculated by two-way repeated measures ANOVA with Tukey-Kramer adjustment. P-value (XLSX)</p
Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: A multicenter, prospective, crossover study
No full textObjectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels 5 the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected. " The Author 2012. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.",,,,,,"10.1093/jac/dks130",,,"http://hdl.handle.net/20.500.12104/41161","http://www.scopus.com/inward/record.url?eid=2-s2.0-84864505008&partnerID=40&md5=bfab9b8f6f474d2558f7de2c5e9a2277",,,,,,"8",,"Journal of Antimicrobial Chemotherapy",,"202
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