Craig W Hendrix

Summary

Affiliation: Johns Hopkins University
Country: USA

Publications

  1. doi request reprint Exploring concentration response in HIV pre-exposure prophylaxis to optimize clinical care and trial design
    Craig W Hendrix
    Department of Medicine Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA Electronic address
    Cell 155:515-8. 2013
  2. pmc MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments
    Craig W Hendrix
    Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
    PLoS ONE 8:e55013. 2013
  3. doi request reprint The clinical pharmacology of antiretrovirals for HIV prevention
    Craig W Hendrix
    Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA
    Curr Opin HIV AIDS 7:498-504. 2012
  4. pmc Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations
    Yanhui Lu
    Department of Pharmacology and Molecular Sciences, Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Antimicrob Agents Chemother 56:2777-9. 2012
  5. pmc Surveillance strategies and impact of vancomycin-resistant enterococcal colonization and infection in critically ill patients
    C W Hendrix
    Department of Medicine Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Ann Surg 233:259-65. 2001
  6. doi request reprint Topical microbicides to prevent HIV: clinical drug development challenges
    Craig W Hendrix
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, USA
    Annu Rev Pharmacol Toxicol 49:349-75. 2009
  7. ncbi request reprint Quantitative imaging and sigmoidoscopy to assess distribution of rectal microbicide surrogates
    C W Hendrix
    Department of Medicine, Division of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    Clin Pharmacol Ther 83:97-105. 2008
  8. ncbi request reprint Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with amprenavir in opioid-dependent subjects
    Craig W Hendrix
    Johns Hopkins University School of Medicine, Baltimore, MD 21287 5554, USA
    Pharmacotherapy 24:1110-21. 2004
  9. ncbi request reprint Safety, pharmacokinetics, and antiviral activity of AMD3100, a selective CXCR4 receptor inhibitor, in HIV-1 infection
    Craig W Hendrix
    Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    J Acquir Immune Defic Syndr 37:1253-62. 2004
  10. ncbi request reprint The effect of isotretinoin on the pharmacokinetics and pharmacodynamics of ethinyl estradiol and norethindrone
    Craig W Hendrix
    Johns Hopkins University, Baltimore, MD 21287, USA
    Clin Pharmacol Ther 75:464-75. 2004

Detail Information

Publications65

  1. doi request reprint Exploring concentration response in HIV pre-exposure prophylaxis to optimize clinical care and trial design
    Craig W Hendrix
    Department of Medicine Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA Electronic address
    Cell 155:515-8. 2013
    ..Pharmacological data illuminate several sources of outcome variability, especially the impact of poor adherence, which is critical to manage PrEP in the clinic and to develop the next generation of PrEP candidates. ..
  2. pmc MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments
    Craig W Hendrix
    Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
    PLoS ONE 8:e55013. 2013
    ....
  3. doi request reprint The clinical pharmacology of antiretrovirals for HIV prevention
    Craig W Hendrix
    Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA
    Curr Opin HIV AIDS 7:498-504. 2012
    ..Pre-exposure prophylaxis (PrEP) clinical trial results using antiretrovirals can seem confusing, if not conflicting. We review recent antiretroviral pharmacokinetic studies to help explain PrEP trial results...
  4. pmc Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations
    Yanhui Lu
    Department of Pharmacology and Molecular Sciences, Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Antimicrob Agents Chemother 56:2777-9. 2012
    ..59 h · μg/ml, respectively, 54% and 52% lower than values from non-Africans. Lower acyclovir concentrations may partly explain the reduced acyclovir suppression of HSV-2 genital ulcer recurrence in HPTN 039 African women participants...
  5. pmc Surveillance strategies and impact of vancomycin-resistant enterococcal colonization and infection in critically ill patients
    C W Hendrix
    Department of Medicine Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Ann Surg 233:259-65. 2001
    ..To determine the optimal site and frequency for vancomycin-resistant enterococci (VRE) surveillance to minimize the number of days of VRE colonization before identification and subsequent isolation...
  6. doi request reprint Topical microbicides to prevent HIV: clinical drug development challenges
    Craig W Hendrix
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, USA
    Annu Rev Pharmacol Toxicol 49:349-75. 2009
    ..These efforts have also advanced the development of numerous methodological approaches to obtain the knowledge needed to improve microbicide development...
  7. ncbi request reprint Quantitative imaging and sigmoidoscopy to assess distribution of rectal microbicide surrogates
    C W Hendrix
    Department of Medicine, Division of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    Clin Pharmacol Ther 83:97-105. 2008
    ..HIV-sized particles migrate retrograde, 60 cm in some studies, 4 h after simulated ejaculation in our model. SPECT/CT, MRI, and endoscopy can be used quantitatively to facilitate rational development of microbicides for rectal use...
  8. ncbi request reprint Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with amprenavir in opioid-dependent subjects
    Craig W Hendrix
    Johns Hopkins University School of Medicine, Baltimore, MD 21287 5554, USA
    Pharmacotherapy 24:1110-21. 2004
    ..To investigate the steady-state pharmacokinetics of methadone enantiomers when coadministered with amprenavir...
  9. ncbi request reprint Safety, pharmacokinetics, and antiviral activity of AMD3100, a selective CXCR4 receptor inhibitor, in HIV-1 infection
    Craig W Hendrix
    Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    J Acquir Immune Defic Syndr 37:1253-62. 2004
    ..Overall, however, the average change in viral load across all patients was +0.03 log10 HIV RNA. Given these results, AMD3100 is not being further developed for ARV therapy, but development continues for stem cell mobilization...
  10. ncbi request reprint The effect of isotretinoin on the pharmacokinetics and pharmacodynamics of ethinyl estradiol and norethindrone
    Craig W Hendrix
    Johns Hopkins University, Baltimore, MD 21287, USA
    Clin Pharmacol Ther 75:464-75. 2004
    ..Although isotretinoin and estradiol are metabolized largely by cytochrome P450 (CYP) 3A4 and glucuronidation, the potential for clinical drug interaction, with subsequent pharmacodynamic impact, has not been evaluated...
  11. doi request reprint Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with fosamprenavir-ritonavir in opioid-dependent subjects
    Ying Jun Cao
    Division of Clinical Pharmacology, Johns Hopkins University, Baltimore, Maryland 21287 5554, USA
    Pharmacotherapy 28:863-74. 2008
    ..To compare steady-state pharmacokinetics and pharmacodynamics of methadone enantiomers when coadministered with fosamprenavir 700 mg-ritonavir 100 mg twice/day...
  12. pmc Single dose pharmacokinetics of oral tenofovir in plasma, peripheral blood mononuclear cells, colonic tissue, and vaginal tissue
    Nicolette A Louissaint
    1 Johns Hopkins University, Baltimore, Maryland
    AIDS Res Hum Retroviruses 29:1443-50. 2013
    ..These and the other pharmacokinetic findings will guide the interpretation and design of future PrEP trials...
  13. pmc Quantification of the spatial distribution of rectally applied surrogates for microbicide and semen in colon with SPECT and magnetic resonance imaging
    Ying J Cao
    Department of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
    Br J Clin Pharmacol 74:1013-22. 2012
    ..These methods are needed to develop rationally rectal microbicides to target and prevent HIV infection...
  14. pmc Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066)
    Craig W Hendrix
    1 Johns Hopkins University, Baltimore, Maryland
    AIDS Res Hum Retroviruses 32:32-43. 2016
    ..Steady-state daily dosing serum TFV and PBMC TFV-DP was consistent with highly effective PrEP clinical trials. HPTN 066 provides adherence benchmarks for oral TFV/FTC regimens to assist interpreting study outcomes. ..
  15. pmc Isoosmolar enemas demonstrate preferential gastrointestinal distribution, safety, and acceptability compared with hyperosmolar and hypoosmolar enemas as a potential delivery vehicle for rectal microbicides
    Francisco J Leyva
    1 Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
    AIDS Res Hum Retroviruses 29:1487-95. 2013
    ..The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle...
  16. pmc Dissimilarities in the metabolism of antiretroviral drugs used in HIV pre-exposure prophylaxis in colon and vagina tissues
    Elaine E To
    Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, 725N Wolfe St, WBSB 302, Baltimore, MD, 21205, USA
    Biochem Pharmacol 86:979-90. 2013
    ..Taken together, these data should help to guide the optimization of small molecules being developed for HIV PrEP. ..
  17. pmc Effect of low-dose ritonavir on the pharmacokinetics of the CXCR4 antagonist AMD070 in healthy volunteers
    Ying Jun Cao
    Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Antimicrob Agents Chemother 52:1630-4. 2008
    ..The plasma pharmacokinetics of ritonavir were consistent with previous reports. It is concluded that AMD070 concentrations were increased with concomitant ritonavir dosing for 14 days in healthy volunteers...
  18. pmc Comparison of Dapivirine Vaginal Gel and Film Formulation Pharmacokinetics and Pharmacodynamics (FAME 02B)
    Jennifer A Robinson
    1 Department of Gynecology and Obstetrics, Johns Hopkins University, Baltimore, Maryland
    AIDS Res Hum Retroviruses . 2016
    ....
  19. pmc Preliminary study of quinine pharmacokinetics in pregnant women with malaria-HIV co-infection
    Kassoum Kayentao
    Malaria Research and Training Center, Faculty of Medicine, Pharmacy and Odontostomatology, University of Sciences, Techniques and Technology of Bamako, Bamako, Mali Howard Hughes Medical Institute Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland
    Am J Trop Med Hyg 90:530-4. 2014
    ..This preliminary observation warrants further research to understand the impact of long-term antiretroviral therapy on the treatment of acute malaria...
  20. doi request reprint Pharmacokinetic effect of AMD070, an Oral CXCR4 antagonist, on CYP3A4 and CYP2D6 substrates midazolam and dextromethorphan in healthy volunteers
    Myaing M Nyunt
    Johns Hopkins University School of Medicine, Division of Clinical Pharmacology, Baltimore, MD, USA
    J Acquir Immune Defic Syndr 47:559-65. 2008
    ..AMD070, a novel entry inhibitor, is an inhibitor of X4-tropic HIV virus. In vitro data suggested that it is a CYP3A4 substrate and may inhibit CYP2D6 and CYP3A4...
  21. pmc Biphasic elimination of tenofovir diphosphate and nonlinear pharmacokinetics of zidovudine triphosphate in a microdosing study
    Jianmeng Chen
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
    J Acquir Immune Defic Syndr 61:593-9. 2012
    ..To evaluate the prediction of microdosing for active intracellular drug metabolites, we compared the PK profile of 2 antiretroviral drugs, zidovudine (ZDV) and tenofovir (TFV), in microdose and standard dosing regimens...
  22. pmc Distribution of cell-free and cell-associated HIV surrogates in the colon after simulated receptive anal intercourse in men who have sex with men
    Nicolette A Louissaint
    Department of Pharmacology and Molecular Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA
    J Acquir Immune Defic Syndr 59:10-7. 2012
    ..Describing the distribution and clearance of HIV surrogates within the gastrointestinal tract to inform rectal microbicide development...
  23. pmc Simultaneous Evaluation of Safety, Acceptability, Pericoital Kinetics, and Ex Vivo Pharmacodynamics Comparing Four Rectal Microbicide Vehicle Candidates
    Francisco Leyva
    1 Department of Medicine Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, Maryland
    AIDS Res Hum Retroviruses 31:1089-97. 2015
    ..We selected the aqueous gel for further development as a rectal microbicide vehicle. ..
  24. ncbi request reprint Noninvasive quantitation of drug concentration in prostate and seminal vesicles: improvement and validation with desipramine and aspirin
    Ying Jun Cao
    Department of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
    J Clin Pharmacol 48:176-83. 2008
    ..91-9.9) for desipramine. We conclude that our quantitative analysis along with the split ejaculate method is sensitive, reproducible, and applicable for the assessment of pharmacokinetics of the accessory glands of the male genital tract...
  25. pmc Compartmentalization and antiviral effect of efavirenz metabolites in blood plasma, seminal plasma, and cerebrospinal fluid
    Lindsay B Avery
    Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
    Drug Metab Dispos 41:422-9. 2013
    ..These data suggest that the male genital tract may be a novel compartment that should be considered in the evaluation of drug metabolite exposure...
  26. ncbi request reprint Amprenavir and lopinavir pharmacokinetics following coadministration of amprenavir or fosamprenavir with lopinavir/ritonavir, with or without efavirenz
    Paul A Pham
    Johns Hopkins Hospital, Baltimore, MD, USA
    Antivir Ther 12:963-9. 2007
    ..Coadministration of these drugs might result in complex pharmacokinetic drug-drug interactions...
  27. pmc Phase I/II evaluation of the prophylactic antimalarial activity of pafuramidine in healthy volunteers challenged with Plasmodium falciparum sporozoites
    Myaing M Nyunt
    Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA
    Am J Trop Med Hyg 80:528-35. 2009
    ..We conclude that a single dose of 100 mg pafuramidine does not adequately protect non-immune individuals against P. falciparum and shows no clinically or statistically significant evidence of causal prophylactic activity...
  28. pmc Levels of Genital Tract Defensins and Cytokines Differ between HIV-Uninfected US and African Women
    Kerry Murphy
    Department of Medicine, Division of Infectious Diseases, Albert Einstein College of Medicine, Bronx, NY, USA
    Am J Reprod Immunol 74:313-22. 2015
    ....
  29. pmc A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02)
    Hiwot Hiruy
    1 Department of Medicine Clinical Pharmacology, Johns Hopkins University, Baltimore, Maryland
    AIDS Res Hum Retroviruses 31:1098-108. 2015
    ..Simultaneous assessment of toxicity, systemic and luminal pharmacokinetics, and colocalization of drug and viral surrogates substantially informs rectal microbicide product development. ..
  30. pmc Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse
    Edward J Fuchs
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287 5554, USA
    J Infect Dis 207:1389-96. 2013
    ..Microbicide toxicity may reduce the efficacy of topical preexposure prophylaxis for human immunodeficiency virus (HIV) transmission. Noninvasive quantitative measures of microbicide toxicity would usefully inform microbicide development...
  31. pmc A phase 1 randomized placebo-controlled safety and pharmacokinetic trial of a tenofovir disoproxil fumarate vaginal ring
    Marla J Keller
    aAlbert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York bJohns Hopkins University School of Medicine, Baltimore, Maryland cNorthwestern University, Evanston, Illinois dParticle Sciences, Inc, Bethlehem, Pennsylvania eFred Hutchinson Cancer Research Center, Seattle, Washington fMagee Women s Research Institute, Pittsburgh, Pennsylvania gUniversity of Colorado, Aurora, Colorado, USA
    AIDS 30:743-51. 2016
    ..We engineered a TDF eluting polyurethane reservoir intravaginal ring (IVR) to provide near constant mucosal antiretroviral concentrations...
  32. ncbi request reprint Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmission
    Edward J Fuchs
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287 5554, USA
    J Infect Dis 195:703-10. 2007
    ..To inform the development of rectal microbicide formulation, we evaluated the effects of hyperosmolar gels on the rectal mucosa...
  33. ncbi request reprint The association between anatomic site of Candida colonization, invasive candidiasis, and mortality in critically ill surgical patients
    Shelley S Magill
    Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
    Diagn Microbiol Infect Dis 55:293-301. 2006
    ..86; 95% confidence interval, 1.05-7.74). Surveillance fungal cultures of particular anatomic sites may help differentiate patients at higher risk of developing IC from those at low risk...
  34. pmc Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir
    Lisa M Noguchi
    Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
    Antimicrob Agents Chemother 60:5616-9. 2016
    ..Tenofovir use was well-tolerated and detected at low levels in maternal serum, milk, and infant serum but demonstrated no anti-HIV activity in milk. ..
  35. pmc Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods
    Yanhui Lu
    School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    Antimicrob Agents Chemother 60:5379-86. 2016
    ..These findings indicate that PRDI was sufficient for population pharmacokinetic model development in this study, with a high level of adherence per multiple measures. ..
  36. pmc Plasma and intracellular ribavirin concentrations are not significantly altered by abacavir in hepatitis C virus-infected patients
    Edward J Fuchs
    Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
    J Antimicrob Chemother 71:1597-600. 2016
    ..The objective of this study was to evaluate the effects of abacavir on intracellular ribavirin triphosphate and plasma ribavirin trough concentrations...
  37. pmc Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial
    Beatrice A Chen
    Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA Magee Womens Research Institute, Pittsburgh, PA Department of Medicine and Infectious Disease, Fenway Institute, Boston, MA Department of Pathology and Medicine, Johns Hopkins University, Baltimore, MD Department of Medicine, University of Alabama at Birmingham, Birmingham, AL Women s Global Health Imperative WGHI RTI International, San Francisco, CA Center for AIDS Prevention Studies, University of California San Francisco, Department of Medicine, San Francisco, CA Statistical Center for HIV AIDS Research and Prevention Fred Hutchinson Cancer Research Center, Seattle, WA NIAID DAIDS, Bethesda, MD International Partnership for Microbicides, Silver Spring, MD FHI 360, Durham, NC and Alpha StatConsult, Damascus, MD
    J Acquir Immune Defic Syndr 70:242-9. 2015
    ..Variable adherence limits effectiveness of daily oral and intravaginal tenofovir-containing pre-exposure prophylaxis. Monthly vaginal antiretroviral rings are one approach to improve adherence and drug delivery...
  38. pmc A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film
    Katherine E Bunge
    Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA Magee Womens Research Institute, Pittsburgh, PA Department of Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD Alpha StatConsult, Damascus, MD International Partnership for Microbicides, Silver Spring, MD and HJF DAIDS, a Division of the Henry M Jackson Foundation for the Advancement of Military Medicine, Inc, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, MD
    J Acquir Immune Defic Syndr 71:498-505. 2016
    ..In this first in-human trial of a vaginal film for delivering the nonnucleoside reverse transcriptase inhibitor dapivirine, safety, pharmacokinetics, and pharmacodynamics of film and gel formulations were compared with placebo...
  39. pmc CYP3A5 genotype impacts maraviroc concentrations in healthy volunteers
    Yanhui Lu
    Department of Pharmacology and Molecular Sciences Y L, C W H, N N B, and Division of Clinical Pharmacology, Department of Medicine E J F, C W H, Johns Hopkins University School of Medicine, Baltimore, Maryland
    Drug Metab Dispos 42:1796-802. 2014
    ..001). In conclusion, the lower maraviroc concentrations in the homozygous wild-type group indicate that maraviroc may be underdosed in people homozygous for the CYP3A5*1 allele, including almost one-half of African Americans. ..
  40. pmc Increasing extracellular protein concentration reduces intracellular antiretroviral drug concentration and antiviral effect
    Lindsay B Avery
    1 Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland
    AIDS Res Hum Retroviruses 29:1434-42. 2013
    ..This study is therefore the first to demonstrate experimentally how protein binding impacts intracellular distribution and the efficacy of ARVs...
  41. pmc RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate
    Peter A Anton
    Center for HIV Prevention Research, UCLA AIDS Institute, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California 90095, USA
    AIDS Res Hum Retroviruses 28:1412-21. 2012
    ..On the basis of increased gastrointestinal AEs, rectally applied, vaginally formulated TFV was not entirely safe or acceptable, suggesting the need for alternative rectal-specific formulations...
  42. doi request reprint Assessing bioequivalence of generic antiepilepsy drugs
    Gregory L Krauss
    Department of Neurology, Johns Hopkins University, Baltimore, MD, USA
    Ann Neurol 70:221-8. 2011
    ....
  43. pmc Impact of fluconazole prophylaxis on cortisol levels in critically ill surgical patients
    Shelley S Magill
    Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 E Monument St, Suite 463A, Baltimore, MD 21287, USA
    Antimicrob Agents Chemother 48:2471-6. 2004
    ..Fluconazole prophylaxis in this population of critically ill surgical patients did not result in significant adrenal dysfunction...
  44. pmc Preexposure prophylaxis-selected drug resistance decays rapidly after drug cessation
    Julie F Weis
    aDivision of Human Biology, Fred Hutchinson Cancer Research CenterbDepartment of Global HealthcDepartment of MedicinedDepartment of Epidemiology, University of WashingtoneDivision of Public Health SciencesfVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WashingtongDepartment of MedicinehDepartment of Pharmacology and Molecular SciencesiDepartment of EpidemiologyjDepartment of Pathology, Johns Hopkins University, Baltimore, Maryland, USAkKenyatta National Hospital, University of Nairobi, Kenya
    AIDS 30:31-5. 2016
    ..PrEP-selected resistance could alter future treatment options, and therefore we sought to determine how long resistance persisted after PrEP cessation...
  45. doi request reprint Comparison of subjective and objective adherence measures for preexposure prophylaxis against HIV infection among serodiscordant couples in East Africa
    Nicholas Musinguzi
    aDepartment of Medicine, Mbarara University of Science and Technology bEpiCentre Médecins Sans Frontières cDepartment of Medical Laboratory Sciences, Mbarara University of Science and Technology, Mbarara, Uganda dDepartment of Infectious Diseases, University of Manitoba, Winnipeg, Canada eDepartment of Medicine, Division of Clinical Pharmacology, Johns Hopkins University, Baltimore, Maryland fDepartment of Global Health gDepartment of Medicine hDepartment of Epidemiology, University of Washington, Seattle, Washington iDepartment of Medicine, Harvard Medical School jDepartment of Global Health and Populations, Harvard T H Chan School of Public Health Center for Global Health, Massachusetts General Hospital, Boston, Massachusetts, USA Members of the The Partners PrEP Ancillary Adherence Study Team have been mentioned under Acknowledgements section
    AIDS 30:1121-9. 2016
    ..Preexposure prophylaxis (PrEP) efficacy is highly dependent on adherence. Yet, it is unclear which adherence measures perform best for PrEP...
  46. pmc Phase 1 clinical trials of DAS181, an inhaled sialidase, in healthy adults
    Jonathan M Zenilman
    Division of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States Electronic address
    Antiviral Res 123:114-9. 2015
    ..This could preclude use of this medication for longer than seven days or for repeated courses. (These studies have been registered at ClinicalTrials.gov under registration Nos. NCT 00527865 and NCT 01651494.). ..
  47. pmc Antiviral activity of genital tract secretions after oral or topical tenofovir pre-exposure prophylaxis for HIV-1
    Betsy C Herold
    Departments of Pediatrics and Microbiology Immunology, Albert Einstein College of Medicine, Yeshiva University, New York, NY University of Pittsburgh, Pittsburgh, PA Magee Womens Research Institute, Pittsburgh, PA University of Washington, Seattle, WA Fred Hutchinson Cancer Research Center, Seattle, WA and Johns Hopkins University, Baltimore, MD
    J Acquir Immune Defic Syndr 66:65-73. 2014
    ..We measured CVL antiviral activity in women using oral or vaginal tenofovir-based pre-exposure prophylaxis and correlated activity with drug and immune mediator levels...
  48. ncbi request reprint Food affects Zidovudine concentration independent of effects on gastrointestinal absorption
    Themba T Ndovi
    Division of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University, Baltimore, MD 21287, USA
    J Clin Pharmacol 47:1366-73. 2007
    ..This effect may be due to the increased hepatic metabolism because feeding increases hepatic blood flow and because ZDV has a high hepatic extraction ratio with low affinity to blood plasma proteins...
  49. pmc Stavudine concentrations in women receiving postpartum antiretroviral treatment and their breastfeeding infants
    Jessica M Fogel
    Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    J Acquir Immune Defic Syndr 60:462-5. 2012
    ..Although d4T is concentrated in breast milk relative to maternal plasma, the infant d4T dose received from breast milk is very small and not clinically significant...
  50. pmc Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial
    Alexander G Agthe
    Department of Pediatrics, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Pediatrics 123:e849-56. 2009
    ..To determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome...
  51. pmc Multiple-dose escalation study of the safety, pharmacokinetics, and biologic activity of oral AMD070, a selective CXCR4 receptor inhibitor, in human subjects
    Nimalie D Stone
    Johns Hopkins University School of Medicine, Division of Clinical Pharmacology, Harvey 502, 600 N Wolfe Street, Baltimore, MD 21287, USA
    Antimicrob Agents Chemother 51:2351-8. 2007
    ..Trough concentrations with the 400-mg dose q12h exceeded the antiviral in vitro 90% effective concentration of AMD070...
  52. ncbi request reprint Enteral fluconazole is well absorbed in critically ill surgical patients
    Robert K Pelz
    Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    Surgery 131:534-40. 2002
    ..Enteral fluconazole, a triazole antifungal agent with an excellent oral bioavailability, has not been widely studied in critically ill surgical patients...
  53. ncbi request reprint A Comparative Pre-Phase I Study of the Impact of Gel Vehicle Volume on Distal Colon Distribution, User Experience, and Acceptability
    Ethel D Weld
    1 Department of Medicine Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, Maryland
    AIDS Res Hum Retroviruses . 2016
    ..Either of these gel volumes could reasonably be pursued for the next phase of development of rectal microbicides...
  54. ncbi request reprint Effects of Obesity and Leptin Deficiency on Morphine Pharmacokinetics in a Mouse Model
    Nicholas M Dalesio
    From the Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland Department of Otolaryngology Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland Department of Pharmacy, and Department of Pediatrics, Johns Hopkins Hospital, Baltimore, Maryland Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland and Department of Anesthesiology, University of Colorado, Aurora, Colorado
    Anesth Analg 123:1611-1617. 2016
    ..We hypothesized that obesity and leptin deficiency impair opioid pharmacokinetics (PK) independently of one another...
  55. pmc A Pilot Study Measuring the Distribution and Permeability of a Vaginal HIV Microbicide Gel Vehicle Using Magnetic Resonance Imaging, Single Photon Emission Computed Tomography/Computed Tomography, and a Radiolabeled Small Molecule
    Edward J Fuchs
    1 The Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland
    AIDS Res Hum Retroviruses 31:1109-15. 2015
    ..043). Spreading gel distributed variably throughout the vagina, persisting for 24 h, with signal concentrating in the fornices and ectocervix. The spreading gel had no significant effect on vaginal mucosal permeability. ..
  56. pmc The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma
    Lauren A Seserko
    Division of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, 600 North Wolfe St, Osler 501, Baltimore, MD 21287, USA
    Bioanalysis 5:2771-83. 2013
    ..Dapivirine is a non-nucleoside reverse transcriptase inhibitor designed to prevent HIV-1 viral replication and subsequent propagation. A sensitive method is required to quantify plasma concentrations to assess drug efficacy...
  57. pmc Cytochrome P450 3A5 plays a prominent role in the oxidative metabolism of the anti-human immunodeficiency virus drug maraviroc
    Yanhui Lu
    Department of Pharmacology and Molecular Sciences, The Johns Hopkins University School of Medicine, 725 N Wolfe St, WBSB 302, Baltimore, MD 21205, USA
    Drug Metab Dispos 40:2221-30. 2012
    ..Taken together, these data provide novel insights into the biotransformation of maraviroc as well as the potential role of CYP3A4 and CYP3A5 divergent residues in the enzymatic activities of these two highly homologous enzymes...
  58. ncbi request reprint Quantitative assessment of seminal vesicle and prostate drug concentrations by use of a noninvasive method
    Themba T Ndovi
    Department of Medicine, Division of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA
    Clin Pharmacol Ther 80:146-58. 2006
    ..Understanding the pharmacokinetics in these compartments should inform rational therapeutics involving these glands...
  59. ncbi request reprint Vancomycin-sensitive and vancomycin-resistant enterococcal infections in the ICU: attributable costs and outcomes
    Robert K Pelz
    Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
    Intensive Care Med 28:692-7. 2002
    ..To determine the economic and clinical outcomes associated with infection with vancomycin-resistant Enterococcus (VRE) and to compare these outcomes to those associated with infection with vancomycin-sensitive Enterococcus (VSE)...
  60. ncbi request reprint Effect of semen sampling frequency on seminal antiretroviral drug concentration
    Y J Cao
    Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    Clin Pharmacol Ther 83:848-56. 2008
    ..However, the concentration of prostate-specific antigen and all three drugs did not decrease, even if the ejaculation intervals decreased to 1 h. Thus, semi-intensive semen sampling can be used to assess MGT pharmacokinetics...
  61. pmc Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patients
    R K Pelz
    Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    Ann Surg 233:542-8. 2001
    ..CONCLUSIONS: Enteral fluconazole safely and effectively decreased the incidence of fungal infections in high-risk, critically ill surgical patients...
  62. pmc Pharmacokinetics and safety of AMD-3100, a novel antagonist of the CXCR-4 chemokine receptor, in human volunteers
    C W Hendrix
    Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA
    Antimicrob Agents Chemother 44:1667-73. 2000
    ....
  63. ncbi request reprint Pharmacokinetics and safety of GW433908 and ritonavir, with and without efavirenz, in healthy volunteers
    Mary Beth Wire
    GlaxoSmithKline, Five Moore Drive, 17 2231 2B, Research Triangle Park, NC 27709, USA
    AIDS 18:897-907. 2004
    ..To evaluate the safety and pharmacokinetic interaction between GW433908, ritonavir (RTV), and efavirenz (EFV)...
  64. ncbi request reprint Enteral fluconazole population pharmacokinetics in patients in the surgical intensive care unit
    Prabhu Rajagopalan
    Department of Clinical Pharmacology, Bayer Pharmaceuticals, West Haven, Connecticut, USA
    Pharmacotherapy 23:592-602. 2003
    ..To determine the population pharmacokinetic parameters of enterally administered fluconazole in patients in a surgical intensive care unit (SICU)...
  65. pmc A new method to estimate quantitatively seminal vesicle and prostate gland contributions to ejaculate
    Themba T Ndovi
    School of Medicine, Department of Medicine, Division of Clinical Pharmacology, Baltimore, Maryland 21287, USA
    Br J Clin Pharmacol 63:404-20. 2007
    ....