Stephen C Piscitelli

Summary

Affiliation: GlaxoSmithKline Research and Development
Country: USA

Publications

  1. pmc Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor
    Steve Piscitelli
    Infectious Diseases MDC, GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    Br J Clin Pharmacol 74:336-45. 2012
  2. ncbi request reprint Evaluation of the drug interaction potential of aplaviroc, a novel human immunodeficiency virus entry inhibitor, using a modified cooperstown 5 + 1 cocktail
    Brendan M Johnson
    GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 46:577-87. 2006
  3. pmc Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, NC, USA Shionogi and Co, Ltd, Osaka, Japan
    Br J Clin Pharmacol 72:103-8. 2011
  4. doi request reprint The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants
    Ivy Song
    GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 51:237-42. 2011
  5. pmc The effects of ritonavir and lopinavir/ritonavir on the pharmacokinetics of a novel CCR5 antagonist, aplaviroc, in healthy subjects
    Kimberly K Adkison
    GlaxoSmithKline, Research Triangle Park, NC, USA
    Br J Clin Pharmacol 62:336-44. 2006
  6. pmc Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, North Carolina 27709, USA
    Antimicrob Agents Chemother 55:3517-21. 2011
  7. doi request reprint In vitro and clinical investigation of the relationship between CCR5 receptor occupancy and anti-HIV activity of Aplaviroc
    James F Demarest
    GlaxoSmith Kline Virology, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 48:1179-88. 2008
  8. doi request reprint Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    J Acquir Immune Defic Syndr 55:365-7. 2010
  9. doi request reprint Pharmacokinetics of the HIV integrase inhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in healthy volunteers
    Parul Patel
    GlaxoSmithKline, Research Triangle Park, NC, USA
    J Antimicrob Chemother 66:1567-72. 2011
  10. doi request reprint Effect of intravenous zanamivir on cardiac repolarization
    Yu Lou
    Infectious Diseases Medicines Discovery and Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Pharmacotherapy 33:701-9. 2013

Collaborators

Detail Information

Publications26

  1. pmc Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor
    Steve Piscitelli
    Infectious Diseases MDC, GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    Br J Clin Pharmacol 74:336-45. 2012
    ....
  2. ncbi request reprint Evaluation of the drug interaction potential of aplaviroc, a novel human immunodeficiency virus entry inhibitor, using a modified cooperstown 5 + 1 cocktail
    Brendan M Johnson
    GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 46:577-87. 2006
    ..63). No significant inhibition of CYP1A2, CYP2C9, CYP2C19, or CYP2D6 enzyme activity was observed. Mild inhibition of CYP3A isozymes should not preclude the use of concomitant CYP3A substrates in future clinical studies with aplaviroc...
  3. pmc Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, NC, USA Shionogi and Co, Ltd, Osaka, Japan
    Br J Clin Pharmacol 72:103-8. 2011
    ..As the primary route of metabolism is via glucuronidation, the effects of atazanavir (ATV, a UGT1A1 inhibitor) and atazanavir/ritonavir (ATV/RTV) on S/GSK1349572 PK were evaluated...
  4. doi request reprint The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants
    Ivy Song
    GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 51:237-42. 2011
    ..The most frequent drug-related AEs were diarrhea, dizziness, and headache. No dosage adjustment for S/GSK1349572 is required when used with lopinavir/ritonavir or darunavir/ritonavir...
  5. pmc The effects of ritonavir and lopinavir/ritonavir on the pharmacokinetics of a novel CCR5 antagonist, aplaviroc, in healthy subjects
    Kimberly K Adkison
    GlaxoSmithKline, Research Triangle Park, NC, USA
    Br J Clin Pharmacol 62:336-44. 2006
    ..This study assessed the effects of the CYP3A inhibitors lopinavir/ritonavir (LPV/r) on the steady-state pharmacokinetics (PK) of aplaviroc (APL), a CYP3A4 substrate, in healthy subjects...
  6. pmc Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, North Carolina 27709, USA
    Antimicrob Agents Chemother 55:3517-21. 2011
    ..The combination of DTG and ETR alone should be avoided; however, DTG may be coadministered with ETR without a dosage adjustment if LPV/RTV or DRV/RTV is concurrently administered...
  7. doi request reprint In vitro and clinical investigation of the relationship between CCR5 receptor occupancy and anti-HIV activity of Aplaviroc
    James F Demarest
    GlaxoSmith Kline Virology, Research Triangle Park, NC 27709, USA
    J Clin Pharmacol 48:1179-88. 2008
    ....
  8. doi request reprint Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, NC 27709, USA
    J Acquir Immune Defic Syndr 55:365-7. 2010
    ..The potential for a drug interaction between S/GSK1349572 and tenofovir disoproxil fumarate (TDF) was evaluated in an open-label, repeat dose, 3-period, drug-drug interaction study in healthy subjects...
  9. doi request reprint Pharmacokinetics of the HIV integrase inhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in healthy volunteers
    Parul Patel
    GlaxoSmithKline, Research Triangle Park, NC, USA
    J Antimicrob Chemother 66:1567-72. 2011
    ..To evaluate the effect of pH-altering agents on S/GSK1349572 exposure in healthy subjects...
  10. doi request reprint Effect of intravenous zanamivir on cardiac repolarization
    Yu Lou
    Infectious Diseases Medicines Discovery and Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Pharmacotherapy 33:701-9. 2013
    ..To assess the effect of a therapeutic and supratherapeutic intravenous dose of the neuraminidase inhibitor zanamivir on QT and rate-corrected QT intervals...
  11. pmc Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Antimicrob Agents Chemother 56:1627-9. 2012
    ..This increase in dolutegravir exposure is not anticipated to impact clinical safety, and therefore dolutegravir can be taken with or without food and without regard to fat content...
  12. doi request reprint Effect of a single supratherapeutic dose of dolutegravir on cardiac repolarization
    Shuguang Chen
    Infectious Diseases Medicines Discovery and Development, GlaxoSmithKline, Research Triangle Park, North Carolina 27709, USA
    Pharmacotherapy 32:333-9. 2012
    ..To assess the effect of a supratherapeutic dose of the integrase inhibitor dolutegravir on the QT and corrected QT (QTc) interval...
  13. pmc Effects of enzyme inducers efavirenz and tipranavir/ritonavir on the pharmacokinetics of the HIV integrase inhibitor dolutegravir
    Ivy Song
    GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, Durham, NC, 27709, USA
    Eur J Clin Pharmacol 70:1173-9. 2014
    ..Dolutegravir (DTG) is an unboosted, integrase inhibitor for the treatment of HIV infection. Two studies evaluated the effects of efavirenz (EFV) and tipranavir/ritonavir (TPV/r) on DTG pharmacokinetics (PK) in healthy subjects...
  14. pmc Pharmacokinetics and short-term safety of 873140, a novel CCR5 antagonist, in healthy adult subjects
    Kimberly K Adkison
    GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, North Carolina 27709, USA
    Antimicrob Agents Chemother 49:2802-6. 2005
    ..Food consumption increased the AUC and C(max) by a mean of 1.7- and 2.2-fold, respectively. The pharmacokinetic and safety profile supports the continued investigation of 873140 with HIV-infected subjects...
  15. pmc Metabolism, excretion, and mass balance of the HIV-1 integrase inhibitor dolutegravir in humans
    Stephen Castellino
    GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Antimicrob Agents Chemother 57:3536-46. 2013
    ..Two minor biotransformation pathways were oxidation by CYP3A4 (7.9% of the dose) and an oxidative defluorination and glutathione substitution (1.8% of the dose). No disproportionate human metabolites were observed. ..
  16. pmc Dolutegravir Has No Effect on the Pharmacokinetics of Oral Contraceptives With Norgestimate and Ethinyl Estradiol
    Ivy H Song
    GlaxoSmithKline, Research Triangle Park, NC, USA
    Ann Pharmacother 49:784-9. 2015
    ..As DTG is administered to HIV-1-infected women receiving oral contraceptives, assessing the potential for drug interactions was warranted...
  17. pmc Effect of fosamprenavir-ritonavir on the pharmacokinetics of dolutegravir in healthy subjects
    Ivy Song
    GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Antimicrob Agents Chemother 58:6696-700. 2014
    ..In the INI-resistant population, as a cautionary measure, alternative combinations that do not include FPV-RTV should be considered. (This study has been registered at ClinicalTrials.gov under identifier NCT01209065.). ..
  18. doi request reprint Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food
    Stephen Weller
    GlaxoSmithKline, Research Triangle Park, NC and GlaxoSmithKline, Collegeville, PA
    J Acquir Immune Defic Syndr 66:393-8. 2014
    ....
  19. pmc A phase 1 study to evaluate the effect of dolutegravir on renal function via measurement of iohexol and para-aminohippurate clearance in healthy subjects
    Justin Koteff
    ViiV Healthcare, Research Triangle Park, North Carolina, USA
    Br J Clin Pharmacol 75:990-6. 2013
    ..The effect of DTG on glomerular filtration rate (GFR), effective renal plasma flow (ERPF), and creatinine clearance (CLcr ) was evaluated in 34 healthy volunteers...
  20. pmc Pharmacokinetics of dolutegravir in HIV-seronegative subjects with severe renal impairment
    Stephen Weller
    GlaxoSmithKline, Research Triangle Park, GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC, 27709, USA
    Eur J Clin Pharmacol 70:29-35. 2014
    ..As renal impairment may affect pharmacokinetics (PK), even for drugs primarily metabolized or secreted in bile, this study investigated the effect of renal impairment on the PK of DTG...
  21. pmc Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers
    Sherene Min
    Infectious Diseases MDC, GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA
    Antimicrob Agents Chemother 54:254-8. 2010
    ..S/GSK1349572 had no impact on midazolam exposure, indicating that it does not modulate CYP3A activity. The PK profile suggests that once-daily, low milligram doses will achieve therapeutic concentrations...
  22. ncbi request reprint Effect of milk thistle on the pharmacokinetics of indinavir in healthy volunteers
    Stephen C Piscitelli
    Department of Pharmacy, National Institutes of Health, Bethesda, Maryland 20892 1880, USA
    Pharmacotherapy 22:551-6. 2002
    ..To characterize the pharmacokinetics of indinavir in the presence and absence of milk thistle and to determine the offset of any effect of milk thistle on indinavir disposition...
  23. ncbi request reprint Concentration-targeted therapy and the future of HIV management
    Charles W Flexner
    AIDS 16:S1-3. 2002
  24. ncbi request reprint A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection
    Mark Dybul
    Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, United States Department of Health and Human Services, Bethesda, Maryland 20892, USA
    J Infect Dis 189:1974-82. 2004
    ..Adherence to such a regimen may be problematic for certain patients...
  25. ncbi request reprint Diarrhea and reduced levels of antiretroviral drugs: improvement with glutamine or alanyl-glutamine in a randomized controlled trial in northeast Brazil
    Oluma Y Bushen
    Center for Global Health, Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA 22908, USA
    Clin Infect Dis 38:1764-70. 2004
    ....
  26. ncbi request reprint Both baseline HIV-1 drug resistance and antiretroviral drug levels are associated with short-term virologic responses to salvage therapy
    John D Baxter
    Cooper Hospital UMDNJ Robert Wood Johnson Medical School, Camden, NJ, USA
    AIDS 16:1131-8. 2002
    ..To determine the impact of HIV-1 drug resistance at baseline and antiretroviral drug levels (DL) during follow-up on virologic response to the next antiretroviral regimen...