Research Topics
| Craig W HendrixSummaryAffiliation: Johns Hopkins University Country: USA Publications
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Publications
MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartmentsCraig W Hendrix
Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
PLoS ONE 8:e55013. 2013....
The clinical pharmacology of antiretrovirals for HIV preventionCraig 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...- Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populationsYanhui 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... 
Quantitative imaging and sigmoidoscopy to assess distribution of rectal microbicide surrogatesC 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...- Topical microbicides to prevent HIV: clinical drug development challengesCraig 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... - Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with amprenavir in opioid-dependent subjectsCraig 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... - Safety, pharmacokinetics, and antiviral activity of AMD3100, a selective CXCR4 receptor inhibitor, in HIV-1 infectionCraig 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... - Surveillance strategies and impact of vancomycin-resistant enterococcal colonization and infection in critically ill patientsC 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... - The effect of isotretinoin on the pharmacokinetics and pharmacodynamics of ethinyl estradiol and norethindroneCraig 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... - Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with fosamprenavir-ritonavir in opioid-dependent subjectsYing 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... - Quantification of the spatial distribution of rectally applied surrogates for microbicide and semen in colon with SPECT and magnetic resonance imagingYing 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... - Effect of low-dose ritonavir on the pharmacokinetics of the CXCR4 antagonist AMD070 in healthy volunteersYing 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... - Distribution of cell-free and cell-associated HIV surrogates in the colon after simulated receptive anal intercourse in men who have sex with menNicolette 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... - Noninvasive quantitation of drug concentration in prostate and seminal vesicles: improvement and validation with desipramine and aspirinYing 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... - Biphasic elimination of tenofovir diphosphate and nonlinear pharmacokinetics of Zidovudine triphosphate in a microdosing studyJianmeng 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... - Amprenavir and lopinavir pharmacokinetics following coadministration of amprenavir or fosamprenavir with lopinavir/ritonavir, with or without efavirenzPaul 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... - Phase I/II evaluation of the prophylactic antimalarial activity of pafuramidine in healthy volunteers challenged with Plasmodium falciparum sporozoitesMyaing 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... - Pharmacokinetic effect of AMD070, an Oral CXCR4 antagonist, on CYP3A4 and CYP2D6 substrates midazolam and dextromethorphan in healthy volunteersMyaing 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... - Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmissionEdward 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... - The association between anatomic site of Candida colonization, invasive candidiasis, and mortality in critically ill surgical patientsShelley 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... - Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourseEdward 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... - RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumaratePeter 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... - Assessing bioequivalence of generic antiepilepsy drugsGregory L Krauss
Department of Neurology, Johns Hopkins University, Baltimore, MD, USA
Ann Neurol 70:221-8. 2011.... - Food affects Zidovudine concentration independent of effects on gastrointestinal absorptionThemba 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... - Impact of fluconazole prophylaxis on cortisol levels in critically ill surgical patientsShelley 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... - Stavudine concentrations in women receiving postpartum antiretroviral treatment and their breastfeeding infantsJessica 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... - Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trialAlexander 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... - Multiple-dose escalation study of the safety, pharmacokinetics, and biologic activity of oral AMD070, a selective CXCR4 receptor inhibitor, in human subjectsNimalie 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... - Enteral fluconazole is well absorbed in critically ill surgical patientsRobert K Pelz
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Surgery 131:534-40. 2002..CONCLUSIONS: Serum fluconazole levels are above the MIC of most yeast species found in these patients. These levels may not be above the MIC of C glabrata, the second most common Candida isolate causing infection in this study... - Compartmentalization and antiviral effect of efavirenz metabolites in blood plasma, seminal plasma, and cerebrospinal fluidLindsay B Avery
Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, 725 North Wolfe Street, Biophysics 307 A, Baltimore, MD 21205 address
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... - Cytochrome P450 3A5 plays a prominent role in the oxidative metabolism of the anti-human immunodeficiency virus drug maravirocYanhui 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... - Vancomycin-sensitive and vancomycin-resistant enterococcal infections in the ICU: attributable costs and outcomesRobert K Pelz
Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
Intensive Care Med 28:692-7. 2002..VRE and VSE infections do not differ in associated cost of ICU care, LOS, or mortality. Any VRE control strategy is be cost-effective if the overall cost per ICU patient-day is less than $304 (348 euros)... - Quantitative assessment of seminal vesicle and prostate drug concentrations by use of a noninvasive methodThemba 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.... - Effect of semen sampling frequency on seminal antiretroviral drug concentrationY 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... - Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patientsR 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... - Pharmacokinetics and safety of AMD-3100, a novel antagonist of the CXCR-4 chemokine receptor, in human volunteersC W Hendrix
Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA
Antimicrob Agents Chemother 44:1667-73. 2000.... - Pharmacokinetics and safety of GW433908 and ritonavir, with and without efavirenz, in healthy volunteersMary Beth Wire
GlaxoSmithKline, Five Moore Drive, 17.2231.2B, Research Triangle Park, NC 27709, USA
AIDS 18:897-907. 2004..However, when EFV is coadministered with the GW433908 1400 mg + RTV 200 mg QD regimen, an increase to RTV 300 mg QD is needed to maintain plasma APV exposure... - Enteral fluconazole population pharmacokinetics in patients in the surgical intensive care unitPrabhu Rajagopalan
Department of Clinical Pharmacology, Bayer Pharmaceuticals, West Haven, Connecticut, USA
Pharmacotherapy 23:592-602. 2003..Fluconazole volume of distribution was larger and half-life was longer in the SICU population than in healthy subjects... - A new method to estimate quantitatively seminal vesicle and prostate gland contributions to ejaculateThemba T Ndovi
School of Medicine, Department of Medicine, Division of Clinical Pharmacology, Baltimore, Maryland 21287, USA
Br J Clin Pharmacol 63:404-20. 2007....